DRUGS & SUPPLEMENTS

Limbival Forte

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Limbival Forte uses

Limbival Forte consists of Amitriptyline, Chlordiazepoxide.

Amitriptyline:


Pharmacological action

Limbival Forte is an antidepressant tricyclic group of compounds derived dibenzocycloheptadiene.

The mechanism of antidepressant action is associated with an increased concentration of norepinephrine in the synapses and / or serotonin in the central nervous system depression due to reverse neuronal capture of these mediators. When anxiety and depressive states this medication reduces anxiety, agitation and depressive symptoms.

Also this drug has some analgesic effect, which is believed to be associated with changes in the concentrations of monoamines in the central nervous system, especially serotonin, and the influence on the endogenous opioid system.

It has distinct peripheral and central anticholinergic action, due to a high affinity for m-cholinergic receptors, a strong sedative effect connected with affinity for histamine H1-receptors and alpha-adrenoceptor blocking action.

Has antiulcer effect mechanism is due to the ability to block histamine H2-receptors in parietal cells of the stomach and provide a sedative and m-anticholinergic action (if gastric ulcer and duodenal ulcer reduces the pain and accelerate healing of ulcers).Its efficiency in the bed-wetting is caused, apparently, anticholinergic activity, which leads to an increase in the ability of the bladder to stretch, direct beta-adrenergic stimulation, the activity of alpha-adrenergic agonists, accompanied by increased tone of the sphincter and the central blockade of serotonin reuptake.

The mechanism of therapeutic action for bulimia nervosa is not installed (possibly similar to that for depression). It shown a clear efficacy of Limbival Forte (Amitriptyline) in bulimia patients without depression, as well as in its presence, and the reduction of bulimia can be observed without a concomitant weakening of the most depressed.

With general anesthesia reduces blood pressure and body temperature. Limbival Forte (Amitriptyline) does not inhibit MAO.

The antidepressant effect develops within 2-3 weeks after application.

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Pharmacokinetics

The bioavailability of Limbival Forte (Amitriptyline) is 30-60%. The plasma protein binding is 82-96%. Vd is 5-10 L / kg. This medicine is metabolized to the active metabolite nortriptyline. T1/2 is 31-46 hours. Limbival Forte (Amitriptyline) excreted primarily by the kidneys.

Why is Limbival Forte prescribed?

Depression (especially with anxiety, agitation and sleep disorders, including childhood, endogenous, involutional, reactive, neurotic, drug, and organic brain damage, alcohol withdrawal), schizophrenic psychoses, mixed emotional disorders, behavioral disorders (activity and attention), nocturnal enuresis (except in patients with hypotonia of the bladder), bulimia nervosa, chronic pain syndrome (chronic pain in cancer patients, migraine, rheumatic pain, atypical facial pain, postherpetic neuralgia, posttraumatic neuropathy, diabetic neuropathy, peripheral neuropathy), prophylaxis of migraine, peptic ulcer and duodenal ulcer.

Dosage and administration

For oral administration the initial dose is 25-50 mg at night. Then, within 5-6 days the dose was increased to an individual 150-200 mg / day. If, during the second week of the improvement has not come, the daily dose increased to 300 mg. With the disappearance of symptoms of depression to reduce the dose of 50-100 mg / day and continue therapy for at least 3 months. In elderly patients with lung disorders the dose is 30-100 mg / day is usually 1 time / at night, after achieving the therapeutic effect switching to the minimum effective dose - 25-50 mg / day.

When nocturnal enuresis in children aged 6-10 years - 10-20 mg / overnight; at the age of 11-16 years - 25-50 mg / day.

For IM injections the initial dose is 50-100 mg / injection in 2-4 injections. If necessary, the dose can be gradually increased to 300 mg / day, in exceptional cases up to 400 mg / day.

Limbival Forte (Amitriptyline) side effects, adverse reactions

CNS and peripheral nervous system: drowsiness, fatigue, fainting, anxiety, confusion, agitation, hallucinations (especially in elderly patients and patients with Parkinson's disease), anxiety, restlessness, mania, hypomania state, aggression, memory impairment, depersonalization, increased depression, decreased ability to concentrate, insomnia, nightmares, yawning, activation of psychosis symptoms, headache, myoclonus, dysarthria, tremor (especially of hands, head and tongue), peripheral neuropathy (paresthesia), myasthenia gravis, myoclonus, ataxia, extrapyramidal syndrome, acceleration and intensification of epileptic seizures, EEG changes.

Cardiovascular system: orthostatic hypotension, tachycardia, conduction disturbances, dizziness, nonspecific ECG changes (ST interval or spike T), arrhythmias, blood pressure lability, impaired intraventricular conduction (widening complex QRS, change the interval PQ, block bundle-branch block).

Digestive system: nausea, heartburn, vomiting, gastralgia, increase or decrease in appetite (increase or decrease in body weight), disease, change in taste, diarrhea, darkening of the tongue, rarely - liver dysfunction, cholestatic jaundice, hepatitis.

Endocrine: testicular swelling, gynecomastia, breast enlargement, galactorrhea, changes in libido, reduced potency, hypo-or hyperglycemia, hyponatremia (decreased production of vasopressin), a syndrome of inappropriate secretion of ADH.

Hematopoietic system: agranulocytosis, leukopenia, thrombocytopenia, purpura, eosinophilia.

Allergic reactions: skin rash, itching, rash, photosensitivity, swelling of the face and tongue.

Effects due to the anticholinergic activity: dry mouth, tachycardia, accommodation disturbances, blurred vision, mydriasis, increased intraocular pressure (only those with a narrow anterior chamber angle), constipation, paralytic ileus, urinary retention, decreased sweating, confusion, delirium or hallucinations.

Other: Hair loss, tinnitus, edema, hyperpyrexia, swollen lymph nodes, pollakiuria, hypoproteinemia.

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Limbival Forte contraindications

The acute period and early recovery period after myocardial infarction, acute alcohol intoxication, acute poisoning with soporific, analgesic and psychotropic drugs, angle-closure glaucoma, severe AV- and intraventricular conduction (bundle branch block feet, AV-block II degree), lactation, children under 6 years of age (for oral administration), children under 12 years (for IV and IM injections), simultaneous treatment with inhibitors and a period of 2 weeks prior to their use, increased sensitivity to Limbival Forte (Amitriptyline) Actavis.

Using during pregnancy and breastfeeding

Limbival Forte should not be used during pregnancy, especially in the I and III trimester, except in cases of extreme necessity. Adequate and well controlled clinical studies on the safety of Limbival Forte (Amitriptyline) during pregnancy was not conducted.

This drug excreted in breast milk and may cause drowsiness in infants.

Taking of Limbival Forte (Amitriptyline) should be phased out, at least 7 weeks prior to delivery to avoid the development of withdrawal syndrome in the newborn.

In experimental studies this medicine exerted teratogenic effects.

Special instructions

Use Limbival Forte (Amitriptyline) with caution in coronary artery disease, arrhythmias, heart block, heart failure, myocardial infarction, hypertension, stroke, chronic alcoholism, thyrotoxicosis, against the background of therapy with thyroid cancer.

The therapy Limbival Forte (Amitriptyline) it needed a caution when sharp transition in the vertical position of the "lying" or "sitting".

With a sharp stop taking may develop withdrawal symptoms.

Limbival Forte (Amitriptyline) in doses of 150 mg / day lowers the threshold of convulsive readiness; it possible a risk of epileptic seizures in susceptible patients, as well as the presence of other factors that increase the risk of seizures (including with traumatic brain injury of any etiology, concomitant use of antipsychotic drugs in the period of refusal or withdrawal of alcohol, drugs with anticonvulsant activity).

It should be noted that patients with depression may attempt suicide.

In conjunction with electroconvulsive therapy it should only be used with careful medical supervision.

In predisposed patients and elderly patients may provoke the development of drug psychosis, mainly at night (after the withdrawal of the drug are within a few days).

Limbival Forte (Amitriptyline) can cause paralytic ileus, mainly in patients with chronic constipation who are elderly or in patients who have to comply with bed rest.

Prior to the general or local anesthesia, the anesthesiologist it should be warned that patients taking Limbival Forte (Amitriptyline).

With prolonged use, an increase the frequency of dental caries. May increase the need for riboflavin.

Limbival Forte (Amitriptyline) may be taken no earlier than 14 days after discontinuation of MAO inhibitors.

The drug should not be used in combination with adrenergic and sympathomimetic, including with epinephrine, ephedrine, isoprenaline, norepinephrine, phenylephrine, phenylpropanolamine.

Use Limbival Forte (Amitriptyline) with caution in conjunction with other drugs, which have anticholinergic action.

While receiving Limbival Forte (Amitriptyline) to avoid drinking alcohol.

During the period of treatment you should refrain from potentially hazardous activities requiring increased attention and rapid psychomotor reactions.

Limbival Forte drug interactions

When this drug applied simultaneously with:

- drugs have a depressing effect on the central nervous system, it is possibly a significant increase in inhibitory action on the central nervous system, hypotensive effect, respiratory depression.

- drugs with anticholinergic activity may increase anticholinergic effects.

- it may be enhance the action of sympathomimetic funds for the cardiovascular system and increase the risk of cardiac arrhythmia, tachycardia, severe hypertension.

- antipsychotic drugs (neuroleptics) are relatively suppressed metabolism, with a reduction in the threshold of convulsive readiness.

- antihypertensive drugs (except clonidine, guanethidine and their derivatives) may increase the antihypertensive action and the risk of orthostatic hypotension.

- with MAO inhibitors may been developed a hypertensive crisis; with clonidine, guanethidine it may be decreased the hypotensive effect of clonidine or guanethidine; with barbiturates, carbamazepine it may be decreased the action of Limbival Forte (Amitriptyline) by increasing its metabolism.

- with sucralfate decreases absorption of Limbival Forte (Amitriptyline); with fluvoxamine - increases the concentration of Limbival Forte (Amitriptyline) in blood plasma and the risk of toxic effects; with fluoxetine - increased concentration of Limbival Forte (Amitriptyline) in plasma and develop toxic reactions due to inhibition of isoenzyme CYP2D6 under the influence of fluoxetine; with quinidine - may slow metabolism of Limbival Forte (Amitriptyline); with cimetidine - may slow metabolism of Limbival Forte (Amitriptyline), increasing its concentration in blood plasma and the development of toxic effects.

While taking alcohol the action of ethanol increases, especially during the first few days of therapy.

There was described a case of serotonin syndrome with simultaneously use with sertraline.

Chlordiazepoxide:


WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

  • Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

DESCRIPTION

Limbival Forte (Chlordiazepoxide) combines in a single capsule formulation the antianxiety action of Limbival Forte (Chlordiazepoxide) hydrochloride and the anticholinergic/spasmolytic effects of clidinium bromide.

Each Limbival Forte (Chlordiazepoxide) capsule contains the active ingredients 5 mg Limbival Forte (Chlordiazepoxide) hydrochloride and 2.5 mg clidinium bromide. Each capsule also contains the inactive ingredients corn starch, lactose monohydrate, talc, methylparaben, propylparaben, potassium sorbate, D&C Yellow No. 10, FD&C Green No. 3, titanium dioxide, and gelatin.

Limbival Forte (Chlordiazepoxide) hydrochloride is a versatile, therapeutic agent of proven value for the relief of anxiety and tension. It is indicated when anxiety, tension or apprehension are significant components of the clinical profile. It is among the safer of the effective psychopharmacologic compounds.

Limbival Forte (Chlordiazepoxide) hydrochloride is 7-chloro-2-methylamino-5-phenyl-3H-1,4-benzodiazepine 4-oxide hydrochloride. A colorless, crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The molecular weight is 336.22. The structural formula of Limbival Forte (Chlordiazepoxide) hydrochloride is as follows:

Clidinium bromide is a synthetic anticholinergic agent which has been shown in experimental and clinical studies to have a pronounced antispasmodic and antisecretory effect on the gastrointestinal tract. Structurally clidinium bromide is:

Chemical Structure Chemical Structure

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ANIMAL PHARMACOLOGY

Limbival Forte hydrochloride has been studied extensively in many species of animals and these studies are suggestive of action on the limbic system of the brain, which recent evidence indicates is involved in emotional responses. Hostile monkeys were made tame by oral drug doses, which did not cause sedation. Limbival Forte (Chlordiazepoxide) hydrochloride revealed a "taming-action with the elimination of fear and aggression”. The taming effect of Limbival Forte (Chlordiazepoxide) hydrochloride was further demonstrated in rats made vicious by lesions in the septal area of the brain. The drug dosage which effectively blocked the vicious reaction was well below the dose which caused sedation in these animals.

The oral LD50 of single doses of Limbival Forte (Chlordiazepoxide) hydrochloride, calculated according to the method of Miller and Tainter, is 720 ± 51 mg/kg as determined in mice observed over a period of 5 days following dosage.

Clidinium bromide is an effective anticholinergic agent with activity approximating that of atropine sulfate against acetylcholine-induced spasms in isolated intestinal strips. On oral administration in mice, it proved an effective antisialagogue in preventing pilocarpine-induced salivation. Spontaneous intestinal motility in both rats and dogs is reduced following oral dosing with 0.1 to 0.25 mg/kg. Potent cholinergic ganglionic blocking effects (vagal) were produced with intravenous usage in anesthetized dogs.

Oral doses of 2.5 mg/kg to dogs produced signs of nasal dryness and slight pupillary dilation. In two other species, monkeys and rabbits, doses of 5 mg/kg, po, given three times daily for 5 days did not produce apparent secretory or visual changes.

The oral LD50 of single doses of clidinium bromide is 860 ± 57 mg/kg as determined in mice observed over a period of 5 days following dosage; the calculations were made according to the method of Miller and Tainter.

Effects on Reproduction

Reproduction studies in rats fed Limbival Forte (Chlordiazepoxide) hydrochloride, 10, 20 and 80 mg/kg daily, and bred through one or two matings showed no congenital anomalies, nor were there adverse effects on lactation of the dams or growth of the newborn. However, in another study at 100 mg/kg daily there was noted a significant decrease in the fertilization rate and a marked decrease in the viability and body weight of offspring which may be attributable to sedative activity, thus resulting in lack of interest in mating and lessened maternal nursing and care of the young. One neonate in each of the first and second matings in the rat reproduction study at the 100 mg/kg dose exhibited major skeletal defects. Further studies are in progress to determine the significance of these findings.

Two series of reproduction experiments with clidinium bromide were carried out in rats, employing dosages of 2.5 and 10 mg/kg daily in each experiment. In the first experiment, clidinium bromide was administered for a 9-week interval prior to mating; no untoward effect on fertilization or gestation was noted. The offspring were taken by caesarean section and did not show a significant incidence of congenital anomalies when compared to control animals. In the second experiment, adult animals were given clidinium bromide for 10 days prior to and through two mating cycles. No significant effects were observed on fertility, gestation, viability of offspring or lactation, as compared to control animals, nor was there a significant incidence of congenital anomalies in the offspring derived from these experiments.

A reproduction study of Limbival Forte (Chlordiazepoxide) was carried out in rats through two successive matings. Oral daily doses were administered in two concentrations: 2.5 mg/kg Limbival Forte (Chlordiazepoxide) hydrochloride with 1.25 mg/kg clidinium bromide or 25 mg/kg Limbival Forte (Chlordiazepoxide) hydrochloride with 12.5 mg/kg clidinium bromide. In the first mating, no significant differences were noted between the control or the treated groups, with the exception of a slight decrease in the number of animals surviving during lactation among those receiving the highest dosage. As with all anticholinergic drugs, an inhibiting effect on lactation may occur. In the second mating, similar results were obtained except for a slight decrease in the number of pregnant females and in the percentage of offspring surviving until weaning. No congenital anomalies were observed in both matings in either the control or treated groups. Additional animal reproduction studies are in progress.

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INDICATIONS AND USAGE

Limbival Forte (Chlordiazepoxide) is indicated to control emotional and somatic factors in gastrointestinal disorders. Limbival Forte (Chlordiazepoxide) may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.

CONTRAINDICATIONS

Limbival Forte (Chlordiazepoxide) is contraindicated in the presence of glaucoma (since the anticholinergic component may produce some degree of mydriasis) and in patients with prostatic hypertrophy and benign bladder neck obstruction. It is contraindicated in patients with known hypersensitivity to Limbival Forte (Chlordiazepoxide) hydrochloride and/or clidinium bromide.

WARNINGS

Concomitant use of benzodiazepines, including Limbival Forte, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe Limbival Forte (Chlordiazepoxide) concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when Limbival Forte (Chlordiazepoxide) is used with opioids (see PRECAUTIONS ).

As in the case of other preparations containing CNS-acting drugs, patients receiving Limbival Forte (Chlordiazepoxide) should be cautioned about possible combined effects with opioids, alcohol and other CNS depressants. For the same reason, they should be cautioned against hazardous occupations requiring complete mental alertness, such as operating machinery or driving a motor vehicle.

Usage In Pregnancy

An increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam and meprobamate) during the first trimester of pregnancy has been suggested in several studies. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug.

As with all anticholinergic drugs, an inhibiting effect on lactation may occur.

OVERDOSAGE

Manifestations of Limbival Forte (Chlordiazepoxide) hydrochloride overdosage include somnolence, confusion, coma and diminished reflexes. Respiration, pulse and blood pressure should be monitored, as in all cases of drug overdosage, although, in general, these effects have been minimal following Limbival Forte (Chlordiazepoxide) hydrochloride overdosage.

While the signs and symptoms of Limbival Forte (Chlordiazepoxide) overdosage may be produced by either of its components, usually such symptoms will be overshadowed by the anticholinergic actions of clidinium bromide. The symptoms of overdosage of clidinium bromide are excessive dryness of mouth, blurring of vision, urinary hesitancy and constipation.

General supportive measures should be employed, along with immediate gastric lavage. Administer physostigmine 0.5 to 2 mg at a rate of no more than 1 mg per minute. This may be repeated in 1 to 4 mg doses if arrhythmias, convulsions or deep coma recur. Intravenous fluids should be administered and an adequate airway maintained. Hypotension may be combated by the use of levarterenol or metaraminol. Methylphenidate or caffeine and sodium benzoate may be given to combat CNS-depressive effects. Dialysis is of limited value. Should excitation occur, barbiturates should not be used. As with the management of intentional overdosage with any drug, it should be borne in mind that multiple agents may have been ingested.

Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines.

PRECAUTIONS

In debilitated patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion capsules per day initially, to be increased gradually as needed and tolerated). In general, the concomitant administration of Limbival Forte (Chlordiazepoxide) and other psychotropic agents is not recommended. If such combination therapy seems indicated, careful consideration should be given to the pharmacology of the agents to be employed - particularly when the known potentiating compounds such as the MAO inhibitors and phenothiazines are to be used. The usual precautions in treating patients with impaired renal or hepatic function should be observed.

Paradoxical reactions to Limbival Forte (Chlordiazepoxide) hydrochloride, e.g., excitement, stimulation and acute rage, have been reported in psychiatric patients and should be watched for during Limbival Forte (Chlordiazepoxide) therapy. The usual precautions are indicated when Limbival Forte (Chlordiazepoxide) hydrochloride is used in the treatment of anxiety states where there is any evidence of impending depression; it should be borne in mind that suicidal tendencies may be present and protective measures may be necessary. Although clinical studies have not established a cause and effect relationship, physicians should be aware that variable effects on blood coagulation have been reported very rarely in patients receiving oral anticoagulants and Limbival Forte (Chlordiazepoxide) hydrochloride.

Information for Patients

Inform patients and caregivers that potentially fatal additive effects may occur if Limbival Forte (Chlordiazepoxide) is used with opioids or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a health care provider (see WARNINGS and PRECAUTIONS ).

To assure the safe and effective use of benzodiazepines, patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug.

Drug Interactions

The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and follow patients closely for respiratory depression and sedation.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Geriatric subjects may be particularly prone to experiencing drowsiness, ataxia and confusion while receiving Limbival Forte (Chlordiazepoxide). These effects can usually be avoided with proper dosage adjustment, although they have occasionally been observed even at the lower dosage ranges. Dosing in geriatric subjects should be initiated cautiously (no more than 2 capsules per day) and increased gradually if needed and tolerated. Limbival Forte (Chlordiazepoxide) is contraindicated in the presence of glaucoma, prostatic hypertrophy and benign bladder neck obstruction.

ADVERSE REACTIONS

No side effects or manifestations not seen with either compound alone have been reported with the administration of Limbival Forte (Chlordiazepoxide). However, since Limbival Forte (Chlordiazepoxide) contains Limbival Forte (Chlordiazepoxide) hydrochloride and clidinium bromide, the possibility of untoward effects which may be seen with either of these two compounds cannot be excluded.

When Limbival Forte (Chlordiazepoxide) hydrochloride has been used alone the necessity of discontinuing therapy because of undesirable effects has been rare. Drowsiness, ataxia and confusion have been reported in some patients - particularly the elderly and debilitated. While these effects can be avoided in almost all instances by proper dosage adjustment, they have occasionally been observed at the lower dosage ranges. In a few instances syncope has been reported.

Other adverse reactions reported during therapy with Limbival Forte (Chlordiazepoxide) hydrochloride include isolated instances of skin eruptions, edema, minor menstrual irregularities, nausea and constipation, extrapyramidal symptoms, as well as increased and decreased libido. Such side effects have been infrequent and are generally controlled with reduction of dosage. Changes in EEG patterns (low-voltage fast activity) have been observed in patients during and after Limbival Forte (Chlordiazepoxide) hydrochloride treatment.

Blood dyscrasias, including agranulocytosis, jaundice and hepatic dysfunction have occasionally been reported during therapy with Limbival Forte (Chlordiazepoxide) hydrochloride. When Limbival Forte (Chlordiazepoxide) hydrochloride treatment is protracted, periodic blood counts and liver function tests are advisable.

Adverse effects reported with use of Limbival Forte (Chlordiazepoxide) are those typical of anticholinergic agents, i.e., dryness of the mouth, blurring of vision, urinary hesitancy and constipation. Constipation has occurred most often when Limbival Forte (Chlordiazepoxide) therapy has been combined with other spasmolytic agents and/or a low residue diet.

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG ABUSE AND DEPENDENCE

Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuance of Limbival Forte (Chlordiazepoxide). The more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving Limbival Forte (Chlordiazepoxide) or other psychotropic agents because of the predisposition of such patients to habituation and dependence.

DOSAGE AND ADMINISTRATION

Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of Limbival Forte varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects. The usual maintenance dose is 1 or 2 capsules, 3 or 4 times a day administered before meals and at bedtime.

Geriatric Dosing

Dosage should be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion. The initial dose should not exceed 2 Limbival Forte (Chlordiazepoxide) capsules per day, to be increased gradually as needed and tolerated.

HOW SUPPLIED

Limbival Forte (Chlordiazepoxide) is available in light green opaque capsules, each containing 5 mg Limbival Forte (Chlordiazepoxide) hydrochloride and 2.5 mg clidinium bromide - bottles of 100 (NDC 0187-4100-10), with Limbival Forte (Chlordiazepoxide) imprinted on the body of the capsule.

Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F).

Keep out of reach of children. Dispense in tight, light-resistant container as defined in USP/NF.

Manufactured by:

Valeant Pharmaceuticals International, Inc.

Steinbach, MB R5G 1Z7 Canada

Manufactured for:

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

Limbival Forte (Chlordiazepoxide) is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.

©Valeant Pharmaceuticals North America LLC

9548900-20001220

Revised: 01/2017

Medication Guide

Limbival Forte (Chlordiazepoxide) (lee braks)

(chlordiazepoxide HCl and clidinium bromide) capsules

What is the most important information I should know about Limbival Forte (Chlordiazepoxide)?

  • Do not stop taking Limbival Forte (Chlordiazepoxide) without first talking to your healthcare provider. Stopping Limbival Forte (Chlordiazepoxide) suddenly can cause serious side effects.
  • Taking Limbival Forte (Chlordiazepoxide) with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death.
  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how Limbival Forte (Chlordiazepoxide) affects you.
  • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Limbival Forte (Chlordiazepoxide) without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, Limbival Forte (Chlordiazepoxide) may make your sleepiness or dizziness much worse.
  • Limbival Forte (Chlordiazepoxide) can cause abuse and dependence.
  • Do not stop taking Limbival Forte (Chlordiazepoxide) all of a sudden. Stopping Limbival Forte (Chlordiazepoxide) suddenly can cause seizures, shaking, stomach and muscle cramps, vomiting and sweating.
  • Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.

What is Limbival Forte (Chlordiazepoxide)?

  • Limbival Forte (Chlordiazepoxide) is a prescription medicine that is used with other therapies for the treatment of:
  • stomach (peptic) ulcers
  • irritable bowel syndrome (IBS)
  • inflammation of the colon called acute enterocolitis
  • Limbival Forte (Chlordiazepoxide) contains the medicines Limbival Forte (Chlordiazepoxide) HCl and clidinium bromide.
  • Limbival Forte (Chlordiazepoxide) can be abused or lead to dependence. Keep Limbival Forte (Chlordiazepoxide) in a safe place to prevent misuse and abuse. Selling or giving away Limbival Forte (Chlordiazepoxide) may harm others. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
  • It is not known if Limbival Forte (Chlordiazepoxide) is safe and effective in children.

Do not take Limbival Forte (Chlordiazepoxide) if you:

  • have glaucoma
  • have an enlarged prostate
  • have a blockage of your bladder that causes problems with urination
  • are allergic to Limbival Forte (Chlordiazepoxide) hydrochloride or clidinium bromide

Before you take Limbival Forte (Chlordiazepoxide), tell your healthcare provider about all of your medical conditions, including if you:

  • have eye problems
  • have problems urinating or emptying your bladder
  • have coordination problems
  • have kidney or liver problems
  • have a history of depression, mental illness, or suicidal thoughts
  • have a history of drug or alcohol abuse or addiction
  • have bleeding problems
  • are pregnant or plan to become pregnant. Limbival Forte (Chlordiazepoxide) may harm your unborn baby. Avoid taking Limbival Forte (Chlordiazepoxide) during the first trimester of pregnancy. Tell your healthcare provider right away if you become pregnant during treatment with Limbival Forte (Chlordiazepoxide).
  • are breastfeeding or plan to breastfeed. Limbival Forte (Chlordiazepoxide) may pass through your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Limbival Forte (Chlordiazepoxide). Limbival Forte (Chlordiazepoxide) may decrease the amount of breast milk your body makes.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Limbival Forte (Chlordiazepoxide) with certain other medicines can cause side effects or affect how well Limbival Forte (Chlordiazepoxide) or the other medicines work.

Do not start or stop other medicines without talking to your healthcare provider.

Especially tell your healthcare provider if you:

  • take a monoamine oxidase inhibitor (MAOI) medicine or an anti-psychotic medicine called phenothiazine.

How should I take Limbival Forte (Chlordiazepoxide)?

  • Take Limbival Forte (Chlordiazepoxide) exactly as your healthcare provider tells you to take it.
  • Your healthcare provider may change your dose of Limbival Forte (Chlordiazepoxide) if needed. Do not change your dose of Limbival Forte (Chlordiazepoxide) or suddenly stop taking Limbival Forte (Chlordiazepoxide) without talking with your healthcare provider.
  • If you take too much Limbival Forte (Chlordiazepoxide), call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of Limbival Forte (Chlordiazepoxide)?

Limbival Forte (Chlordiazepoxide) may cause serious side effects, including: See “What is the most important information I should know about Limbival Forte (Chlordiazepoxide)?”

The most common side effects of Limbival Forte (Chlordiazepoxide) include:

  • dry mouth
  • blurred vision
  • nausea
  • constipation
  • skin problems
  • swelling
  • irregular menstrual (periods) cycles
  • increase and decreased desire for sex (libido)
  • problems starting to urinate
  • drowsiness, coordination problems, and confusion may happen, especially in people who are elderly or weak

These are not all the possible side effects of Limbival Forte (Chlordiazepoxide).

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

How should I store Limbival Forte (Chlordiazepoxide)?

  • Store Limbival Forte (Chlordiazepoxide) at room temperature 77°F (25°C).
  • Keep Limbival Forte (Chlordiazepoxide) and all medicines out of the reach of children.

General information about the safe and effective use of Limbival Forte (Chlordiazepoxide).

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Limbival Forte (Chlordiazepoxide) for a condition for which it was not prescribed. Do not give Limbival Forte (Chlordiazepoxide) to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Limbival Forte (Chlordiazepoxide) that is written for health professionals.

What are the ingredients in Limbival Forte (Chlordiazepoxide)?

Active ingredient: Limbival Forte (Chlordiazepoxide) hydrochloride and clidinium bromide

Inactive ingredients: corn starch, lactose and talc. Gelatin capsule shells may contain methyl and propyl parabens and potassium sorbate, with the following dye systems: D&C Yellow No. 10 and either FD&C Blue No.1 or FD&C Green No. 3.

Manufactured in Canada by: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 1Z7 Canada

Manufactured for: Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA

Limbival Forte (Chlordiazepoxide) is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.

©Valeant Pharmaceuticals North America LLC

For more information, go to www.valeant.com or contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576

This Medication Guide has been approved by the U.S. Food and Drug Administration

Issued: 01/2017

NDC 0187-4100-10

Rx Only

Limbival Forte (Chlordiazepoxide)®

(chlordiazepoxide HCl)

(clidinium bromide)

Each capsule

contains 5 mg

Limbival Forte (Chlordiazepoxide)

HCl and 2.5 mg

clidinium bromide.

VALEANT

100 Capsules

Limbival Forte pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Limbival Forte available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Limbival Forte destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Limbival Forte Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Limbival Forte pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "chlordiazepoxide". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "amitriptyline". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Limbival Forte?

Depending on the reaction of the Limbival Forte after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Limbival Forte not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Limbival Forte addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Limbival Forte, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Limbival Forte consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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