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Tofranil injection

imipramine hydrochloride USP

Dosage Form: injection

Tofranil®

imipramine hydrochloride USP

Ampuls

For intramuscular administration

Prescribing Information

DESCRIPTION

Tofranil, imipramine hydrochloride USP, the original tricyclic antidepressant, is available in ampuls for intramuscular administration. Each 2 mL ampul contains imipramine hydrochloride USP, 25 mg; ascorbic acid, 2 mg; sodium bisulfite, 1 mg; sodium sulfite, anhydrous, 1 mg. Tofranil is a member of the dibenzazepine group of compounds. It is designated 5-[3- (dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride. Its structural formula is

Imipramine hydrochloride USP is a white to off-white, odorless, or practically odorless crystalline powder. It is freely soluble in water and in alcohol, soluble in acetone, and insoluble in ether and in benzene. Its molecular weight is 316.87.

CLINICAL PHARMACOLOGY

The mechanism of action of Tofranil is not definitely known. However, it does not act primarily by stimulation of the central nervous system. The clinical effect is hypothesized as being due to potentiation of adrenergic synapses by blocking uptake of norepinephrine at nerve endings. The mode of action of the drug in controlling childhood enuresis is thought to be apart from its antidepressant effect.

INDICATIONS AND USAGE

Depression: For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.

CONTRAINDICATIONS

The concomitant use of monoamine oxidase inhibiting compounds is contraindicated. Hyperpyretic crises or severe convulsive seizures may occur in patients receiving such combinations. The potentiation of adverse effects can be serious, or even fatal. When it is desired to substitute Tofranil in patients receiving a monoamine oxidase inhibitor, as long an interval should elapse as the clinical situation will allow, with a minimum of 14 days. Initial dosage should be low and increases should be gradual and cautiously prescribed.

The drug is contraindicated during the acute recovery period after a myocardial infarction. Patients with a known hypersensitivity to this compound should not be given the drug. The possibility of cross-sensitivity to other dibenzazepine compounds should be kept in mind.

WARNINGS

Children: A dose of 2.5 mg/kg/day of imipramine hydrochloride should not be exceeded in childhood. ECG changes of unknown significance have been reported in pediatric patients with doses twice this amount.

Extreme caution should be used when this drug is given to: patients with cardiovascular disease because of the possibility of conduction defects, arrhythmias, congestive heart failure, myocardial infarction, strokes and tachycardia. These patients require cardiac surveillance at all dosage levels of the drug; patients with increased intraocular pressure, history of urinary retention, or history of narrow-angle glaucoma because of the drug's anti-cholinergic properties; hyperthyroid patients or those on thyroid medication because of the possibility of cardiovascular toxicity; patients with a history of seizure disorder because this drug has been shown to lower the seizure threshold; patients receiving guanethidine, clonidine, or similar agents, since imipramine hydrochloride may block the pharmacologic effects of these drugs; patients receiving methylphenidate hydrochloride. Since methylphenidate hydrochloride may inhibit the metabolism of imipramine hydrochloride, downward dosage adjustment of imipramine hydrochloride may be required when given concomitantly with methylphenidate hydrochloride.

Tofranil may enhance the CNS depressant effects of alcohol. Therefore, it should be borne in mind that the dangers inherent in a suicide attempt or accidental overdosage with the drug may be increased for the patient who uses excessive amounts of alcohol. (See PRECAUTIONS.)

Since imipramine hydrochloride may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as operating an automobile or machinery, the patient should be cautioned accordingly.

Contains sodium sulfite and sodium bisulfite, that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably 1ow. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

PRECAUTIONS

General

An ECG recording should be taken prior to the initiation of larger-than-usual doses of imipramine hydrochloride and at appropriate intervals thereafter until steady state is achieved. (Patients with any evidence of cardiovascular disease require cardiac surveillance at all dosage levels of the drug. See WARNINGS.) Elderly patients and patients with cardiac disease or a prior history of cardiac disease are at special risk of developing the cardiac abnormalities associated with the use of imipramine hydrochloride.

It should be kept in mind that the possibility of suicide in seriously depressed patients is inherent in the illness and may persist until significant remission occurs. Such patients should be carefully supervised during the early phase of treatment with imipramine hydrochloride, and may require hospitalization. Prescriptions should be written for the smallest amount feasible.

Hypomanic or manic episodes may occur, particularly in patients with cyclic disorders.

Such reactions may necessitate discontinuation of the drug. If needed, imipramine hydrochloride may be resumed in lower dosage when these episodes are relieved.

Administration of a tranquilizer may be useful in controlling such episodes.

An activation of the psychosis may occasionally be observed in schizophrenic patients and may require reduction of dosage and the addition of a phenothiazine.

Concurrent administration of imipramine hydrochloride with electroshock therapy may increase the hazards; such treatment should be limited to those patients for whom it is essential, since there is limited clinical experience.

Patients taking imipramine hydrochloride should avoid excessive exposure to sunlight since there have been reports of photosensitization.

Both elevation and lowering of blood sugar levels have been reported with imipramine hydrochloride use.

Imipramine hydrochloride should be used with caution in patients with significantly impaired renal or hepatic function.

Patients who develop a fever and a sore throat during therapy with imipramine hydrochloride should have leukocyte and differential blood counts performed. Imipramine hydrochloride should be discontinued if there is evidence of pathologic neutrophil depression.

Prior to elective surgery, imipramine hydrochloride should be discontinued for as long as the clinical situation will allow.

Drug Interactions

Drugs Metabolized by P450 2D6

The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the Caucasian population (about 7%-10% of Caucasians are so-called "poor metabolizers"); reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African, and other populations are not yet available. Poor metabolizers have higher than expected plasma concentrations of tricyclic antidepressants (TGAs) when given usual doses. Depending on the fraction of drug metabolized by P450 2D6, the increase in plasma concentration may be small, or quite large (8-fold increase in plasma AUC of the TCA).

In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. The extent to which SSRI-TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the co-administration of TCAs with any of the SSRIs and also in switching from one class to the other. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).

Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be co-administered with another drug known to be an inhibitor of P450 2D6.

The plasma concentration of imipramine may increase when the drug is given concomitantly with hepatic enzyme inhibitors (e.g., cimetidine, fluoxetine) and decrease by concomitant administration with hepatic enzyme inducers (e.g., barbiturates, phenytoin), and adjustment of the dosage of imipramine may therefore be necessary.

In occasional susceptible patients or in those receiving anticholinergic drugs (including antiparkinsonism agents) in addition, the atropine-like effects may become more pronounced (e.g., paralytic ileus). Close supervision and careful adjustment of dosage is required when imipramine hydrochloride is administered concomitantly with anticholinergic drugs.

Avoid the use of preparations, such as decongestants and local anesthetics, that contain any sympathomimetic amine (e.g., epinephrine, norepinephrine), since it has been reported that tricyclic antidepressants can potentiate the effects of catecholamines.

Caution should be exercised when imipramine hydrochloride is used with agents that lower blood pressure. Imipramine hydrochloride may potentiate the effects of CNS depressant drugs.

Patients should be warned that imipramine hydrochloride may enhance the CNS depressant effects of alcohol (See WARNINGS.)

Usage During Pregnancy and Lactation

Animal reproduction studies have yielded inconclusive results. (See also ANIMAL PHARMACOLOGY & TOXICOLOGY.)

There have been no well-controlled studies conducted with pregnant women to determine the effect of imipramine hydrochloride on the fetus. However, there have been clinical reports of congenital malformations associated with the use of the drug. Although a causal relationship between these effects and the drug could not be established, the possibility of fetal risk from the maternal ingestion of imipramine hydrochloride cannot be excluded. Therefore, imipramine hydrochloride should be used in women who are or might become pregnant only if the clinical condition clearly justifies potential risk to the fetus.

Limited data suggest that imipramine hydrochloride is likely to be excreted in human breast milk. As a general rule, a woman taking a drug should not nurse since the possibility exists that the drug may be excreted in breast milk and be harmful to the child.

Usage in Children

The effectiveness of the drug in children for conditions other than nocturnal enuresis given orally has not been established.

ADVERSE REACTIONS

Note: Although the listing which follows includes a few adverse reactions which have not been reported with this specific drug, the pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when imipramine is administered.

Cardiovascular

Orthostatic hypotension, hypertension, tachycardia, palpitation, myocardial infarction. arrhythmias, heart block, ECG changes, precipitation of congestive heart failure, stroke.

Psychiatric

Confusional states (especially in the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia and nightmares; hypomania; exacerbation of psychosis.

Neurological

Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alterations in EEG patterns; tinnitus.

Anticholinergic

Dry mouth, and, rarely, associated sublingual adenitis; blurred vision, disturbances of accommodation, mydriasis; constipation, paralytic ileus; urinary retention, delayed micturition, dilation of the urinary tract.

Allergic

Skin rash, petechiae, urticaria, itching, photosensitization; edema (general or of face and tongue); drug fever; cross sensitivity with desipramine.

Hematologic

Bone marrow depression including agranulotosis; eosinophilia; purpura; thrombocytopenia.

Gastrointestinal

Nausea and vomiting, anorexia, epigastric distress, diarrhea; peculiar taste, stomatitis, abdominal cramps, black tongue.

Endocrine

Gynecomastia in the male; breast enlargement and galactorrhea in the female; increased or decreased libido, impotence; testicular swelling; elevation or depression of blood sugar levels; inappropriate antidiuretic hormone (ADH) secretion syndrome.

Other

Jaundice (simulating obstructive); altered liver function; weight gain or loss; perspiration; flushing; urinary frequency; drowsiness, dizziness, weakness and fatigue; headache; parotid swelling; alopecia; proneness to falling.

Withdrawal Symptoms

Though not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache and malaise.

DOSAGE AND ADMINISTRATION

Initially, up to 100 mg/day intramuscularly in divided doses.

Parenteral administration should be used only for starting therapy in patients unable or unwilling to use oral medication. The oral form should supplant the injectable as soon as possible.

Lower dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients as compared to hospitalized patients who will be under close supervision. Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. Following remission, oral maintenance medication may be required for a longer period of time, at the lowest dose that will maintain remission.

OVERDOSAGE

Children have been reported to be more sensitive than adults to an acute overdosage of imipramine hydrochloride. An acute overdose of any amount in infants or young children, especially, must be considered serious and potentially fatal.

Signs and Symptoms

These may vary in severity depending upon factors such as the amount of drug absorbed, the age of the patient, and the interval between drug ingestion and the start of treatment. Blood and urine levels of imipramine may not reflect the severity at poisoning; they have chiefly a qualitative rather than quantitative value, and are unreliable indicators in the clinical management of the patient.

CNS abnormalities may include drowsiness, stupor, coma, ataxia, restlessness, agitation, hyperactive reflexes, muscle rigidity, athetoid and choreiform movements, and convulsions.

Cardiac abnormalities may include arrhythmia, tachycardia, ECG evidence of impaired conduction, and signs of congestive failure. Respiratory depression, cyanosis, hypotension, shock, vomiting, hyperpyrexia, mydriasis, and diaphoresis may also be present.

Treatment

The recommended treatment for overdosage with tricyclic antidepressants may change periodically. Therefore, it is recommended that the physician contact a poison control center for current information on treatment. Because CNS involvement, respiratory depression and cardiac arrhythmia can occur suddenly, hospitalization and close observation may be necessary, even when the amount ingested is thought to be small or the initial degree of intoxication appears slight or moderate. All patients with ECG abnormalities should have continuous cardiac monitoring and be closely observed until well after cardiac status has returned to normal; relapses may occur after apparent recovery.

In the alert patient, empty the stomach promptly by lavage. In the obtunded patient, secure the airway with a cuffed endotracheal tube before beginning lavage (do not induce emesis). Instillation of activated charcoal slurry may help reduce absorption of imipramine.

Minimize external stimulation to reduce the tendency to convulsions. If anticonvulsants are necessary, diazepam and phenytoin may be useful.

Maintain adequate respiratory exchange. Do not use respiratory stimulants.

Shock should be treated with supportive measures, such as appropriate position, intravenous fluids, and, if necessary, a vasopressor agent. The use of corticosteroids in shock is controversial and may be contraindicated in cases of overdosage with tricyclic antidepressants. Digitalis may increase conduction abnormalities and further irritate an already sensitized myocardium. If congestive heart failure necessitates rapid digitalization, particular care must be exercised.

Hyperpyrexia should be controlled by whatever external means are available, including ice packs and cooling sponge baths, if necessary.

Hemodialysis, peritoneal dialysis, exchange transfusions and forced diuresis have been generally reported as ineffective because of the rapid fixation of imipramine in tissues. Blood and urine levels of imipramine may not correlate with the degree of intoxication, and are unreliable indicators in the clinical management of the patient.

The slow intravenous administration of physostigmine salicylate has been used as a last resort to reverse severe CNS anticholinergic manifestations of overdosage with tricyclic anti- depressants; however, it should not be used routinely, since it may induce seizures and cholinergic crises.

HOW SUPPLIED

Ampuls 2 mL – For intramuscular administration only

25 mg imipramine hydrochloride, 2 mg ascorbic acid, 1 mg sodium bisulfite, 1 mg sodium sulfite, anhydrous

Boxes of 10 ........................................................................................ NDC 0028-0065-23

Store between 59º-86ºF (15º-30ºC).

Note: Upon storage, minute crystals may form in some ampuls. This has no influence on the therapeutic efficacy of the preparation, and the crystals redissolve when the affected ampuls are immersed in hot tap water for 1 minute.

ANIMAL PHARMACOLOGY & TOXICOLOGY

A. Acute: Oral LD50 ranges are as follows:

Rat 355 to 682 mg/kg

Dog 100 to 215 mg/kg

Depending on the dosage in both species, toxic signs proceeded progressively from depression, irregular respiration and ataxia to convulsions and death.

B. Reproduction/Teratogenic: The overall evaluation may be summed up in the following manner:

Oral: Independent studies in three species (rat, mouse, and rabbit) revealed that when Tofranil is administered orally in doses up to approximately 2 ½ times the maximum human dose in the first 2 species and up to 25 times the maximum human dose in the third species, the drug is essentiality free from teratogenic potential. In the three species studied, only one instance of fetal abnormality occurred (in the rabbit) and in that study there was likewise an abnormality in the control group. However, evidence does exist from the rat studies that some systemic and embryotoxic potential is demonstrable. This is manifested by reduced litter size, a slight increase in the stillborn rate and a reduction in the mean birth weight.

Parenteral: In contradistinction to the oral data, Tofranil does exhibit a slight but definite teratogenic potential when administered by the subcutaneous route. Drug effects on both the mother and fetus in the rabbit are manifested in higher resorption rates and decrease in mean fetal birth weights, while teratogenic findings occurred at a level of 5 times the maximum human dose. In the mouse, teratogenicity occurred at 1 ½ and 6 ½ times the maximum human dose, but no teratogenic effects were seen at levels 3 times the maximum human dose. Thus, in the mouse, the findings are equivocal.

667764

C94-15 (Rev. 7/94)

Geigy

Dist. by: Geigy Pharmaceuticals

Ciba-Geigy Corporation

Ardsley, New York 10502

Tofranil
imipramine hydrochloride injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0028-0065
Route of Administration	INTRAMUSCULAR	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
imipramine hydrochloride (imipramine)	Active	25 MILLIGRAM In 2 MILLILITER
ascorbic acid	Inactive	2 MILLIGRAM In 2 MILLILITER
sodium bisulfite	Inactive	1 MILLIGRAM In 2 MILLILITER
sodium sulfite, anhydrous	Inactive	1 MILLIGRAM In 2 MILLILITER

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0028-0065-23	10 AMPULE In 1 BOX	contains a AMPULE
1		2 mL (MILLILITER) In 1 AMPULE	This package is contained within the BOX (0028-0065-23)

Revised: 10/2006Geigy Pharmaceuticals

More Tofranil resources

Tofranil Side Effects (in more detail)
Tofranil Use in Pregnancy & Breastfeeding
Drug Images
Tofranil Drug Interactions
Tofranil Support Group
9 Reviews for Tofranil - Add your own review/rating

Compare Tofranil with other medications

ADHD
Depression
Interstitial Cystitis
Night Terrors
Pain
Panic Disorder
Primary Nocturnal Enuresis

Kuvan

Generic Name: sapropterin (Oral route)

sap-roe-TER-in

Commonly used brand name(s)

In the U.S.

Kuvan

Available Dosage Forms:

Tablet, Disintegrating

Uses For Kuvan

Sapropterin is used to lower phenylalanine levels in the blood of patients with phenylketonuria (PKU). High levels of phenylalanine (an amino acid) in the blood can cause severe brain damage, including severe mental retardation, seizures, tremors, or decreased learning ability. This medicine is usually given along with a special diet .

This medicine is available only with your doctor's prescription .

Before Using Kuvan

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sapropterin in children below 4 years of age. Safety and efficacy have not been established .

Geriatric

Appropriate studies on the relationship of age to the effects of sapropterin have not been performed in the geriatric population. Safety and efficacy have not been established .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of Kuvan

It is best to take this medicine with food at the same time each day .

Mix the tablets in 4 to 8 ounces (1/2 to 1 cup) of water or apple juice before taking. It may take a few minutes for the tablets to dissolve. To make the tablets dissolve faster, you may stir or crush them. Drink this mixture within 15 minutes .

Carefully follow your doctor's instructions about any special diet. It is important that you maintain a diet with restricted amounts of phenylalanine .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):
- Adults and children 4 years of age and older—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 10 milligrams (mg) per kilogram (kg) of body weight per day. Your doctor may adjust your dose if needed.
- Children below 4 years of age—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Kuvan

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects .

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements .

Kuvan Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Fever

Incidence not determined

Seizures

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Cough

diarrhea

headache

runny nose

vomiting

Less common

Bruising

stuffy nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Kuvan side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Kuvan resources

Kuvan Side Effects (in more detail)
Kuvan Use in Pregnancy & Breastfeeding
Kuvan Drug Interactions
Kuvan Support Group
0 Reviews for Kuvan - Add your own review/rating

Kuvan Prescribing Information (FDA)

Kuvan Monograph (AHFS DI)

Kuvan MedFacts Consumer Leaflet (Wolters Kluwer)

Kuvan Consumer Overview

Compare Kuvan with other medications

Phenylketonuria

Tagamet HB Drug Facts

Generic Name: cimetidine

Dosage Form: tablet
Drug Facts

Active ingredient

Cimetidine 200 mg

Purpose

Acid reducer

Uses

relieves heartburn associated with acid indigestion and sour stomach

prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Warnings

Allergy alert:

Do not use if you are allergic to cimetidine or other acid reducers

Do not use

if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.

with other acid reducers

Ask a doctor before use if you have

frequent chest pain

frequent wheezing, particularly with heartburn

unexplained weight loss

nausea or vomiting

stomach pain

had heartburn over 3 months. This may be a sign of a more serious condition.

heartburn with lightheadedness, sweating or dizziness

chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness

Ask a doctor or pharmacist before use if you are taking

theophylline (oral asthma medicine)

warfarin (blood thinning medicine)

phenytoin (seizure medicine)

If you are not sure you are taking one of these medicines, talk to your doctor or pharmacist.

Drug Interaction Warnings:

Tagamet HB 200® may interfere with the action of drugs prescribed by your doctor. Check with your doctor before taking Tagamet HB 200® if you are taking blood thinning medication (e.g. Warfarin) or drugs prescribed for asthma (e.g. Theophylline) or epilepsy (e.g. Phenytoin).

Brand names of some medicines which contain one of these ingredients include:
THEOPHYLLINE	THEO-DUR® Theochron® Slo-Bid® Uniphyl® Theo-24®
WARFARIN	Coumadin®
PHENYTOIN	Dilantin®

There may be other medicines that contain one of these ingredients. If in doubt about this or about possible effects of Tagamet HB 200 on any other medicines you are taking, talk to your doctor or pharmacist.

Read the directions and warnings before taking this medication.

Stop use and ask a doctor if

your heartburn continues or worsens

stomach pain continues

you need to take this product for more than 14 days

If pregnant or breast-feeding,

ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and over:
- to relieve symptoms, swallow 1 tablet with a glass of water
- to prevent symptoms, swallow 1 tablet with a glass of water right before or any time up to 30 minutes before eating food or drinking beverages that cause heartburn
- do not take more than 2 tablets in 24 hours

children under 12 years: ask a doctor

Other information

store at 15-30oC (59-86oF)

Inactive ingredients

cellulose, corn starch, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide

Questions and comments?

call toll-free 1-800-482-4394 (English/Spanish) weekdays

Principal Display Panel

Tagamet HB 200®

Cimetidine Tablets 200 mg/Acid Reducer

30 TABLETS (30 DOSES)

Just ONE TABLET RELIEVES

and PREVENTS Heartburn and Acid Indigestion

Take ANY TIME you need it:

Before Meal

During Meal

After Meal

Read and retain the important drug interaction warnings printed on the inside of this carton

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Twp, PA 15108, Made in Ireland

For more information, visit tagamethb.com

TAGAMET HB
cimetidine tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	0135-0148
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CIMETIDINE (CIMETIDINE)	CIMETIDINE	200 mg

Inactive Ingredients
Ingredient Name	Strength
POWDERED CELLULOSE
STARCH, CORN
HYPROMELLOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL
POLYSORBATE 80
POVIDONE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE

Product Characteristics
Color	WHITE	Score	no score
Shape	DIAMOND	Size	13mm
Flavor		Imprint Code	TAGAMET;200
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0135-0148-02	6 TABLET In 1 BLISTER PACK	None
2	0135-0148-05	30 TABLET In 1 BLISTER PACK	None
3	0135-0148-06	60 TABLET In 1 BLISTER PACK	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020238	03/19/2010

Labeler - GlaxoSmithKline Consumer Healthcare LP (091328625)

Revised: 03/2010GlaxoSmithKline Consumer Healthcare LP

More Tagamet HB Drug Facts resources

Tagamet HB Drug Facts Side Effects (in more detail)
Tagamet HB Drug Facts Use in Pregnancy & Breastfeeding
Drug Images
Tagamet HB Drug Facts Drug Interactions
Tagamet HB Drug Facts Support Group
3 Reviews for Tagamet HB Drug Facts - Add your own review/rating

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Duodenal Ulcer
Duodenal Ulcer Prophylaxis
Erosive Esophagitis
GERD
Human Papilloma Virus
Indigestion
Lung Cancer
Obesity
Stomach Ulcer
Stress Ulcer Prophylaxis
Upper GI Hemorrhage
Zollinger-Ellison Syndrome

Wednesday, June 27, 2012

Konsyl Orange Sugar-free

Generic Name: psyllium (SIL ee um)

Brand Names: Fiberall, Hydrocil, Konsyl, Konsyl Orange Sugar-free, Konsyl-D, Konsyl-Orange, Laxmar, Laxmar Orange, Laxmar Sugar Free, Metamucil, Metamucil Berry Burst Smooth Texture Sugar Free, Metamucil Orange Coarse Milled Original Texture, Metamucil Orange Smooth Texture, Metamucil Orange Smooth Texture Sugar Free, Metamucil Original Texture Regular, Metamucil Pink Lemonade Smooth Texture Sugar-Free, Metamucil Unflavored Coarse Milled Original Texture, Metamucil Unflavored Smooth Texture Sugar Free, Natural Fiber Therapy, Perdiem Fiber Powder, Reguloid

What is Konsyl Orange Sugar-free (psyllium)?

Psyllium is a bulk-forming fiber laxative. Psyllium works by absorbing liquid in the intestines and swelling to create a softer, bulky stool that is easier to pass.

Psyllium is used to treat occasional constipation or bowel irregularity. Psyllium may also be used to treat diarrhea and may help lower cholesterol when used together with a diet low in cholesterol and saturated fat.

Psyllium may also be used for purposes not listed in this product guide.

What is the most important information I should know about Konsyl Orange Sugar-free (psyllium)?

Laxatives may be habit-forming if they are used too often or for too long. This can lead to damage of intestinal nerves or muscle tissues. Do not take psyllium for longer than directed on the label or prescribed by your doctor. You should not take this product if you are allergic to psyllium, or if you have trouble swallowing, a sudden change in bowel habits that lasts longer than 2 weeks, severe nausea, vomiting, or stomach pain, or if you have ever had a skin rash while taking psyllium.

Also talk with your doctor before using psyllium if you have a colostomy or ileostomy, rectal bleeding, or a blockage in your intestines.

Stop using psyllium and call your doctor at once if you have choking or trouble swallowing, severe stomach pain or cramping, nausea or vomiting, constipation that lasts longer than 7 days, rectal bleeding, or itchy skin rash. Do not take psyllium for longer than 7 days in a row unless your doctor has told you to.

What should I discuss with my healthcare provider before taking Konsyl Orange Sugar-free (psyllium)?

trouble swallowing;

a sudden change in bowel habits that lasts longer than 2 weeks;

severe nausea, vomiting, or stomach pain; or

if you have ever had a skin rash while taking psyllium.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

a colostomy or ileostomy;

rectal bleeding; or

a blockage in your intestines.

Psyllium products may contain sugar, sodium, or artificial sweeteners. This may be of concern to you if you have diabetes, high blood pressure, or phenylketonuria (PKU). Check the product label if you have any of these conditions.

Psyllium is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether psyllium passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Konsyl Orange Sugar-free (psyllium)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Take psyllium with a full glass (at least 8 ounces) of water or another liquid. Taking psyllium without enough liquid may cause it to swell in your throat and cause choking. Drinking plenty of fluids each day while you are taking psyllium will also help improve bowel regularity.

The psyllium wafer must be chewed before you swallow it.

Do not swallow psyllium powder dry. It must be mixed with liquid. Place the psyllium powder into an empty glass and add at least 8 ounces of water or other liquid such as fruit juice. Stir this mixture and drink all of it right away.

If the powder and liquid mixture is too thick, add more liquid. After drinking the entire mixture, add a little more liquid to the same glass, swirl gently and drink right away to make sure you get the entire dose of psyllium.

Psyllium may be only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

It may take up to 3 days of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 2 or 3 days of treatment.

Do not take psyllium for longer than 7 days in a row unless your doctor has told you to. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since psyllium is used as needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using psyllium.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, and stomach pain. Using a laxative too often or for too long may cause severe medical problems involving your intestines.

What should I avoid while taking Konsyl Orange Sugar-free (psyllium)?

Avoid taking other oral (by mouth) medications within 2 hours before or after you take psyllium. Bulk-forming laxatives can make it harder for your body to absorb other medications, possibly making them less effective.

Avoid breathing in the dust from psyllium powder when mixing. Inhaling psyllium dust may cause an allergic reaction.

If you take psyllium as part of a cholesterol-lowering treatment plan, avoid eating foods that are high in fat or cholesterol. Your treatment will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Konsyl Orange Sugar-free (psyllium) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using psyllium and call your doctor at once if you have a serious side effect such as:

choking or trouble swallowing;

severe stomach pain, cramping, nausea or vomiting;

constipation that lasts longer than 7 days;

rectal bleeding; or

itchy skin rash.

Less serious side effects may include:

bloating; or

minor change in your bowel habits.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Konsyl Orange Sugar-free (psyllium)?

Tell your doctor about all other medications you use, especially:

a blood thinner such as warfarin (Coumadin, Jantoven); or

demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

This list is not complete and other drugs may interact with psyllium. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Konsyl Orange Sugar-free resources

Konsyl Orange Sugar-free Side Effects (in more detail)
Konsyl Orange Sugar-free Use in Pregnancy & Breastfeeding
Konsyl Orange Sugar-free Drug Interactions
0 Reviews for Konsyl Orange Sugar-free - Add your own review/rating

Konsyl Powder MedFacts Consumer Leaflet (Wolters Kluwer)

Metamucil MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Konsyl Orange Sugar-free with other medications

Constipation
Dietary Fiber Supplementation
Irritable Bowel Syndrome

Where can I get more information?

Your pharmacist can provide more information about psyllium.

See also: Konsyl Orange Sugar-free side effects (in more detail)

Sunday, June 24, 2012

Acetaminophen/Hydrocodone

Pronunciation: a-SEET-a-MIN-oh-fen/HYE-droe-KOE-done
Generic Name: Acetaminophen/Hydrocodone
Brand Name: Examples include Vicodin and Lortab

Acetaminophen/Hydrocodone contains acetaminophen. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor.

Acetaminophen/Hydrocodone is used for:

Treatment of moderate to moderately severe pain. It may also be used for other conditions as determined by your doctor.

Acetaminophen/Hydrocodone is an analgesic combination. Acetaminophen works by lowering a chemical in the brain that stimulates pain nerves. Hydrocodone, an opioid (narcotic) analgesic, works by binding to receptors in the brain and nervous system used by the body's natural "pain relievers." The combination may provide better pain relief than either medicine alone.

Do NOT use Acetaminophen/Hydrocodone if:

you are allergic to any ingredient in Acetaminophen/Hydrocodone

you have diarrhea associated with poisoning, antibiotic use, or a bacterial infection (from eating or drinking contaminated food or water)

you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Acetaminophen/Hydrocodone:

Some medical conditions may interact with Acetaminophen/Hydrocodone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you are allergic to other narcotic medicines (eg, medicines that contain codeine, morphine, oxycodone)

if you have or have ever had alcoholism, substance abuse, narcotic dependence, or if you consume more than 3 alcoholic drinks per day

if you have considered or attempted suicide

if you have acute head injury, increased pressure in the head, brain injury or tumor, epilepsy, or seizures (convulsions)

if you are having an asthma attack

if you have an acute stomach or intestinal problem, chronic inflammation and ulceration of the bowel, or recent abdominal surgery; adrenal gland problems; enlargement of the prostate gland; heart failure or lung disease, including shortness of breath; liver or kidney problems; thyroid disease; urinary blockage; or viral hepatitis

Some MEDICINES MAY INTERACT with Acetaminophen/Hydrocodone. Tell your health care provider if you are taking any other medicines, especially any of the following:

Barbiturate anesthetics (eg, thiopental), cimetidine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), tricyclic antidepressants (eg, amitriptyline), or sodium oxybate (GHB) because serious side effects, such as increased sleepiness and decreased ability to breathe, may occur

Naltrexone because it may decrease Acetaminophen/Hydrocodone's effectiveness and withdrawal symptoms may occur in patients who have become physically dependent on opioids

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen/Hydrocodone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Acetaminophen/Hydrocodone:

Use Acetaminophen/Hydrocodone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Acetaminophen/Hydrocodone by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

If you miss a dose of Acetaminophen/Hydrocodone, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen/Hydrocodone.

Important safety information:

Acetaminophen/Hydrocodone may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Acetaminophen/Hydrocodone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Acetaminophen/Hydrocodone; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

Acetaminophen/Hydrocodone may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.

Acetaminophen/Hydrocodone has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Acetaminophen/Hydrocodone may harm your liver. Your risk may be greater if you drink alcohol while you are using Acetaminophen/Hydrocodone. Talk to your doctor before you take Acetaminophen/Hydrocodone or other fever reducers if you drink more than 3 drinks with alcohol per day.

Use Acetaminophen/Hydrocodone with caution in the ELDERLY; they may be more sensitive to its effects, especially possible decreased breathing and drowsiness.

Acetaminophen/Hydrocodone should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Acetaminophen/Hydrocodone while you are pregnant. Acetaminophen/Hydrocodone is found in breast milk. Do not breast-feed while taking Acetaminophen/Hydrocodone.

When used for long periods of time or at high doses, Acetaminophen/Hydrocodone may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Acetaminophen/Hydrocodone stops working well. Do not take more than prescribed.

Some people who use Acetaminophen/Hydrocodone for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Acetaminophen/Hydrocodone, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Acetaminophen/Hydrocodone:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; constipation; difficulty breathing; dizziness; drowsiness; flushing; lightheadedness; mental/mood changes; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; change in the amount of urine; change or loss in hearing; fear; interrupted breathing; mental or mood changes; unusual tiredness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Acetaminophen/Hydrocodone side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bluish skin; cold/clammy skin; difficult or slow breathing; drowsiness leading to unresponsiveness or coma; excessive sweating; loss of function in the heart and lungs; nausea and vomiting; pinpoint pupils; seizure (convulsions); stomach or intestinal pain.

Proper storage of Acetaminophen/Hydrocodone:

Store Acetaminophen/Hydrocodone at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Do not refrigerate. Do not freeze. Dispense in tight, light-resistant container. Keep Acetaminophen/Hydrocodone out of the reach of children and away from pets.

General information:

If you have any questions about Acetaminophen/Hydrocodone, please talk with your doctor, pharmacist, or other health care provider.

Acetaminophen/Hydrocodone is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Acetaminophen/Hydrocodone. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Acetaminophen/Hydrocodone resources

Acetaminophen/Hydrocodone Side Effects (in more detail)
Acetaminophen/Hydrocodone Dosage
Acetaminophen/Hydrocodone Use in Pregnancy & Breastfeeding
Drug Images
Acetaminophen/Hydrocodone Drug Interactions
Acetaminophen/Hydrocodone Support Group
370 Reviews for Acetaminophen/Hydrocodone - Add your own review/rating

Compare Acetaminophen/Hydrocodone with other medications

Back Pain
Cough
Pain
Rheumatoid Arthritis

Friday, June 22, 2012

Loratadine Orally Disintegrating Tablets

Pronunciation: lor-A-ta-deen
Generic Name: Loratadine
Brand Name: Examples include Claritin Reditabs and Triaminic Allerchews

Loratadine Orally Disintegrating Tablets are used for:

Relieving symptoms of seasonal allergies such as runny nose; sneezing; itchy, watery eyes; or itching of the nose and throat. It may also be used for other conditions as determined by your doctor.

Loratadine Orally Disintegrating Tablets are an antihistamine. It works by blocking a substance in the body called histamine. This helps to decrease allergy symptoms.

Do NOT use Loratadine Orally Disintegrating Tablets if:

you are allergic to any ingredient in Loratadine Orally Disintegrating Tablets

Contact your doctor or health care provider right away if any of these apply to you.

Before using Loratadine Orally Disintegrating Tablets:

Some medical conditions may interact with Loratadine Orally Disintegrating Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have kidney or liver problems, or phenylketonuria (PKU)

Some MEDICINES MAY INTERACT with Loratadine Orally Disintegrating Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Amiodarone because the risk of severe irregular heartbeat may be increased

Ask your health care provider if Loratadine Orally Disintegrating Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Loratadine Orally Disintegrating Tablets:

Use Loratadine Orally Disintegrating Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Loratadine Orally Disintegrating Tablets by mouth with or without food.

Be sure that your hands are completely dry before you handle Loratadine Orally Disintegrating Tablets. Use the tablet right away after you remove it from the tablet blister.

To open the tablet blister, peel back the foil, then gently remove the tablet. Place the tablet on the tongue. The tablet will dissolve quickly. You may take Loratadine Orally Disintegrating Tablets with or without water.

If you miss a dose of Loratadine Orally Disintegrating Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Loratadine Orally Disintegrating Tablets.

Important safety information:

Taking Loratadine Orally Disintegrating Tablets in high doses may cause drowsiness. Do NOT take more than the recommended dose without checking with your doctor.

Loratadine Orally Disintegrating Tablets may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Loratadine Orally Disintegrating Tablets for a few days before the tests.

Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.

Loratadine Orally Disintegrating Tablets should not be used in CHILDREN younger than 6 years old without checking with the child's doctor; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Loratadine Orally Disintegrating Tablets while you are pregnant. Loratadine Orally Disintegrating Tablets are found in breast milk. If you are or will be breast-feeding while you use Loratadine Orally Disintegrating Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Loratadine Orally Disintegrating Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe or persistent dizziness.

See also: Loratadine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fast or irregular heartbeat; severe drowsiness or headache.

Proper storage of Loratadine Orally Disintegrating Tablets:

Store Loratadine Orally Disintegrating Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Do not use a tablet if the blister unit is open or torn. Use within 6 months of opening the foil pouch. Keep Loratadine Orally Disintegrating Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Loratadine Orally Disintegrating Tablets, please talk with your doctor, pharmacist, or other health care provider.

Loratadine Orally Disintegrating Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Loratadine Orally Disintegrating Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Loratadine resources

Loratadine Side Effects (in more detail)
Loratadine Use in Pregnancy & Breastfeeding
Drug Images
Loratadine Drug Interactions
Loratadine Support Group
21 Reviews for Loratadine - Add your own review/rating

Compare Loratadine with other medications

Hay Fever
Urticaria

Wednesday, June 20, 2012

Maxiflu DM

Generic Name: acetaminophen, dextromethorphan, guaifenesin, and pseudoephedrine (a SEET a MIN oh fen, DEX troe me THOR fan, gwye FEN e sin, SOO doe ee FED rin)

Brand Names: Duraflu, Maxiflu DM, Robitussin Cold Cough and Flu, Theraflu Chest and Cough, Theraflu Max-D Severe Cold & Flu, Tylenol Cold Severe Congestion Non-Drowsy

What is Maxiflu DM (acetaminophen, dextromethorphan, guaifenesin, and pseudoephedrine)?

Acetaminophen is a pain reliever and fever reducer.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of acetaminophen, dextromethorphan, guaifenesin, and pseudoephedrine is used to treat headache, fever, body aches, cough, chest congestion, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.

Acetaminophen, dextromethorphan, guaifenesin, and pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about this medicine?

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

What should I discuss with my healthcare provider before taking this medicine?

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take acetaminophen, dextromethorphan, guaifenesin, and pseudoephedrine if you have:

liver disease, cirrhosis, or a history of alcoholism;

diabetes;

glaucoma;

diabetes;

epilepsy or other seizure disorder;

enlarged prostate or urination problems;

pheochromocytoma (an adrenal gland tumor); or

cough with mucus, or cough caused by emphysema or chronic bronchitis.

It is not known whether acetaminophen, dextromethorphan, guaifenesin, and pseudoephedrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant. Acetaminophen, dextromethorphan, guaifenesin, and pseudoephedrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Artificially sweetened cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take this medicine?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

What happens if I miss a dose?

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking this medicine?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen.

This medicine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. chest pain, fast, slow, or uneven heart rate; Stop using this medication and call your doctor at once if you have any of these serious side effects:

chest pain, fast, slow, or uneven heart rate;

severe dizziness, feeling like you might pass out;

mood changes, confusion, hallucinations;

tremor, seizure (convulsions);

fever;

urinating less than usual or not at all;

nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or

dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

Less serious side effects may include:

dizziness, weakness;

mild headache;

mild nausea, diarrhea, upset stomach;

dry mouth, nose, or throat;

feeling nervous, restless, irritable, or anxious; or

sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect this medicine?

Ask a doctor or pharmacist if it is safe for you to take this medicine if you are also using any of the following drugs:

leflunomide (Arava);

tapentadol (Nucynta);

an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

an antidepressant;

birth control pills or hormone replacement therapy;

blood pressure medication;

cancer medicine;

cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

gout or arthritis medications (including gold injections);

HIV/AIDS medication;

medicines to treat psychiatric disorders;

migraine headache medicine;

an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

seizure medication.

This list is not complete and other drugs may interact with acetaminophen, dextromethorphan, guaifenesin, and pseudoephedrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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Cold Symptoms
Cough and Nasal Congestion

Where can I get more information?

Your pharmacist can provide more information about acetaminophen, dextromethorphan, guaifenesin, and pseudoephedrine.

Tuesday, June 19, 2012

Nicorette 15mg Patch (McNeil Products Ltd)

1. Name Of The Medicinal Product

Nicorette 15mg Patch or Boots NicAssist 15 mg Patch

2. Qualitative And Quantitative Composition

Nicotine, 15mg released over 16 hours use. Each patch is 30 sq.cm, containing nicotine 0.83mg/sq.cm.

For excipients see section 6.1

3. Pharmaceutical Form

Transdermal Patch

4. Clinical Particulars

4.1 Therapeutic Indications

Nicorette Patch is indicated for the relief of nicotine withdrawal symptoms as an aid to smoking cessation in adults and children over 12 years of age. It is also indicated in pregnant and lactating women (see section 4.6).

If possible, Nicorette Patch should be used in conjunction with a behavioural support programme.

4.2 Posology And Method Of Administration

The patient should make every effort to stop smoking completely during treatment with Nicorette Patch.

Behavioural therapy, advice and support will normally improve the success rate.

Nicorette Patch should be applied to clean, dry intact areas of hairless skin, for example on the hip, upper arm, or chest. These areas should be varied each day and the same site should not be used on consecutive days.

There is no clinically significant difference in bioavailability of nicotine when the patch is applied to either the hip, upper arm or chest.

Adults (over 18 years of age)

The daily dose is one patch delivering 15mg, 10mg or 5mg nicotine as appropriate, with application limited to 16 hours in a 24 hour period in each case.

Daily treatment commences with one 15mg (30cm²) patch, applied on waking (usually in the morning) and removed 16 hours later (usually at bedtime).

After removal, used patches should be disposed of carefully (see warnings).

Treatment should continue at this dose for an initial period of 8 weeks. Patients who have successfully abstained from smoking during this 8 week period should be supported through a further 4 week weaning period, using the lower strength patches. Downward titration of dose is achieved by applying one 10mg (20cm²) patch daily for 2 weeks followed by one 5mg (10cm²) patch daily for a further 2 weeks.

Adults who use NRT beyond 9 months are recommended to seek additional help and advice from a healthcare professional.

Adolescents (12 to 18 years)

The dose and method of use are as for adults however as data are limited in this age group, the recommended treatment duration is 12 weeks. If longer treatment is required, advice from a healthcare professional should be sought.

4.3 Contraindications

Nicorette Patches should not be administered to patients with known hypersensitivity to nicotine or any component of the patch.

4.4 Special Warnings And Precautions For Use

Any risks that may be associated with NRT are substantially outweighed by the well established dangers of continued smoking.

Underlying cardiovascular disease: In stable cardiovascular disease Nicorette Patch presents a lesser hazard than continuing to smoke. However dependent smokers currently hospitalised as a result of myocardial infarction, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, Nicorette Patch may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision.

Diabetes mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.

Renal or hepatic impairment: Nicorette Patch should be used with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.

Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. After removal, the patch should be folded in half, adhesive side innermost, and placed inside the opened sachet, or in a piece of aluminium foil. The used patch should then be disposed of carefully, away from the reach of children or animals.

Phaeochromocytoma and uncontrolled hyperthyroidism: As nicotine causes release of catecholamines, Nicorette Patch should be used with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma.

Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical importance for products with a narrow therapeutic window, e.g. theophylline, clozapine and ropinirole.

Generalised dermatological disorders :Patients with chronic generalised dermatological disorders such as psoriasis, chronic dermatitis or urticaria should not use Nicorette Patch.

Erythema may occur. If it is severe or persistent, treatment should be discontinued.

Minor skin reactions are seen at the patch application site in a proportion of patients when commencing treatment (see also section 4.8). If skin reactions become more severe or more generalized, patients should be advised to discontinue use of patches and seek further medical help regarding nicotine replacement therapy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically relevant interactions between nicotine replacement therapy and other drugs has definitely been established. However nicotine may possibly enhance the haemodynamic effects of adenosine i.e. increase in blood pressure and heart rate and also increase pain response (angina-pectoris type chest pain) provoked by adenosine administration.

4.6 Pregnancy And Lactation

Pregnancy

NRT is not contraindicated in pregnancy. The decision to use NRT should be made on a risk-benefit assessment as early on in the pregnancy as possible with the aim of discontinuing use as soon as possible.

Smoking during pregnancy is associated with risks such as intra-uterine growth retardation, premature birth or stillbirth. Stopping smoking is the single most effective intervention for improving the health of both pregnant smoker and her baby. The earlier abstinence is achieved the better.

Ideally smoking cessation during pregnancy should be achieved without NRT. However for women unable to quit on their own, NRT may be recommended to assist a quit attempt.

Nicotine passes to the fetus affecting breathing movements and has a dose-dependent effect on placental/fetal circulation. However the risk of using NRT to the fetus is lower than that expected with tobacco smoking, due to lower maximal plasma nicotine concentration and no additional exposure to polycyclic hydrocarbons and carbon monoxide.

Intermittent dosing products may be preferable as these usually provide a lower daily dose of nicotine than patches. However, patches may be preferred if the women is suffering from nausea during pregnancy. If patches are used they should be removed before going to bed.

Lactation

NRT is not contraindicated in lactation. Nicotine from smoking and NRT is found in breast milk. However the amount of nicotine the infant is exposed to is relatively small and less hazardous than the second-hand smoke they would otherwise be exposed to.

Using intermittent dose NRT preparations, compared with patches, may minimize the amount of nicotine in the breast milk as the time between administrations of NRT and feeding can be more easily prolonged.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can include; irritability/aggression, dysphoria/depressed mood, anxiety, restlessness, poor concentration, increased appetite/weight gain, urges to smoke (cravings), night-time awakenings/sleep disturbance and decreased heart rate.

Increased frequency of aphthous ulcer may occur after abstinence from smoking. The causality is unclear.

Nicorette Patch may cause adverse reactions similar to those associated with nicotine given by other means, including smoking, and these are mainly dose-dependent. At recommended doses Nicorette Patch has not been found to cause any serious adverse effects. Excessive use of Nicorette Patch by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.

About 20% of Nicorette patch users experience mild local skin reactions, during the first weeks of treatment. In some patients the skin reactions may become more severe eg skin blistering or a burning sensation or may be more generalized (see section 4.4).

Reported adverse events associated with Nicorette 5mg, 10mg and 15mg patch include:

Body System	Incidence*	Reported adverse event
Nervous system disorders:	Common:	Dizziness, headache
Cardiac disorders:	Uncommon:	Palpitations
	Very rare:	Reversible atrial fibrillation
Gastrointestinal disorders:	Common:	Gastrointestinal discomfort, nausea, vomiting
Skin and subcutaneous tissue disorders:	Uncommon:	Urticaria
General disorders and administration site disorders:	Very common:	Itching
	Common:	Erythema

*Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1 000, <1/100); rare (>1/10 000, <1/1 000); very rare (<1/10 000), including isolated reports.

4.9 Overdose

Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.

Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Nicotine has no therapeutic uses except as replacement therapy for the relief of abstinence symptoms in nicotine-dependent smokers.

Owing to its many actions, the overall effects of nicotine are complex. A wide variety of stimulant and depressant effects are observed that involve the central and peripheral nervous, cardiovascular, endocrine, gastro-intestinal and skeletal motor systems. Nicotine acts on specific binding sites or receptors throughout the nervous system.

5.2 Pharmacokinetic Properties

Taking into account the residual concentration of nicotine in the transdermal system, the nicotine released from the system is efficiently absorbed: a bioavailability of between 80-100% has been reported. There is no clinically significant difference in bioavailability of nicotine when the patch is applied to either the hip, upper arm or chest.

Steady state concentrations of plasma nicotine in volunteers were examined during a study period of six days. Although nicotine was detectable 24 hours after the first dose, the data did not indicate any accumulation.

Tmax of nicotine after application of a 30cm² nicotine transdermal system has been shown to vary between 6 ± 2 and 9 ± 3 hours: Cmax has been shown to vary between 13 ± 3 and 16 ± 5 ng/ml. No differences in these pharmacokinetic parameters have been observed between males and females.

All Nicorette Patches are labelled by the average amount of nicotine absorbed by the patient over 16 hours.

5.3 Preclinical Safety Data

Preclinical data indicate that nicotine is neither mutagenic nor genotoxic.

There are no other findings derived from preclinical testing of relevance to the prescriber in determining the safety of the product which have not been considered in other relevant sections of this Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Medium molecular weight polyisobutylene

Low molecular weight polyisobutylene

Polybutylene

Polyester non-woven backing film

Siliconised polyester release liner

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Do not store at above 30^oC.

6.5 Nature And Contents Of Container

Heat sealed multilaminate pouch containing one patch. Cartons of 1, 2, 3, 7*, 14* and 28 pouches (*pack presently marketed).

6.6 Special Precautions For Disposal And Other Handling

Cut open the pouch with scissors along the line, as indicated. A clean, dry intact area of skin is selected which is hairless, such as the hip, upper arm or chest. The transparent plastic backing is peeled away and the patch pressed carefully onto the skin. The fingers should be rubbed firmly round the edge to ensure that the patch sticks properly. The patch will normally resist bathing, showering, or swimming, but if it does come off it should be replaced with a new one. Use of skin oils or talc can prevent proper adhesion of the patch.

It is intended that the patch is worn through the waking hours (approximately 16 hours) being applied on waking and removed at bedtime. Nicotine residues in the used patches may present a hazard to children and pets, thus used patches should be folded, sticky sides together, put back in an empty pouch and placed in household rubbish.

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

8. Marketing Authorisation Number(S)

PL 15513/0177

9. Date Of First Authorisation/Renewal Of The Authorisation

22 January 2008

10. Date Of Revision Of The Text

20 April 2010

Thursday, June 28, 2012

DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS AND USAGE

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

General

Drug Interactions

Usage During Pregnancy and Lactation

Usage in Children

ADVERSE REACTIONS

Cardiovascular

Psychiatric

Neurological

Anticholinergic

Allergic

Hematologic

Gastrointestinal

Endocrine

Other

Withdrawal Symptoms

DOSAGE AND ADMINISTRATION

OVERDOSAGE

Signs and Symptoms

Treatment

HOW SUPPLIED

ANIMAL PHARMACOLOGY & TOXICOLOGY

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Commonly used brand name(s)

Uses For Kuvan

Before Using Kuvan

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of Kuvan

Dosing

Missed Dose

Storage

Precautions While Using Kuvan

Kuvan Side Effects

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Active ingredient

Purpose

Uses

Warnings

Allergy alert:

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are taking

Stop use and ask a doctor if

If pregnant or breast-feeding,

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Wednesday, June 27, 2012

What is Konsyl Orange Sugar-free (psyllium)?

What is the most important information I should know about Konsyl Orange Sugar-free (psyllium)?

What should I discuss with my healthcare provider before taking Konsyl Orange Sugar-free (psyllium)?

How should I take Konsyl Orange Sugar-free (psyllium)?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking Konsyl Orange Sugar-free (psyllium)?

Konsyl Orange Sugar-free (psyllium) side effects

What other drugs will affect Konsyl Orange Sugar-free (psyllium)?

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Sunday, June 24, 2012