Name of the medicinal product

Gabantip-AT

Qualitative and quantitative composition

Amitriptyline (Gabantip-AT) hydrochloride is a dibenzocycloheptene-derivative tricyclic antidepressant (TCA). TCAs are structurally similar to phenothiazines. They contain a tricyclic ring system with an alkyl amine substituent on the central ring. In non-depressed individuals, Amitriptyline (Gabantip-AT) does not affect mood or arousal, but may cause sedation. In depressed individuals, Amitriptyline (Gabantip-AT) exerts a positive effect on mood. TCAs are potent inhibitors of serotonin and norepinephrine reuptake. Tertiary amine TCAs, such as Amitriptyline (Gabantip-AT), are more potent inhibitors of serotonin reuptake than secondary amine TCAs, such as nortriptyline. TCAs also down-regulate cerebral cortical β-adrenergic receptors and sensitize post-synaptic serotonergic receptors with chronic use. The antidepressant effects of TCAs are thought to be due to an overall increase in serotonergic neurotransmission. TCAs also block histamine-H1 receptors, α1-adrenergic receptors and muscarinic receptors, which accounts for their sedative, hypotensive and anticholinergic effects (e.g. blurred vision, dry mouth, constipation, urinary retention), respectively. See toxicity section below for a complete listing of side effects. Amitriptyline (Gabantip-AT) may be used to treat depression, chronic pain (unlabeled use), irritable bowel syndrome (unlabeled use), diabetic neuropathy (unlabeled use), post-traumatic stress disorder (unlabeled use), and for migraine prophylaxis (unlabeled use).

Amitriptyline hydrochloride (Gabantip-AT) is a dibenzocycloheptene-derivative tricyclic antidepressant (TCA). TCAs are structurally similar to phenothiazines. They contain a tricyclic ring system with an alkyl amine substituent on the central ring. In non-depressed individuals, Amitriptyline hydrochloride (Gabantip-AT) does not affect mood or arousal, but may cause sedation. In depressed individuals, Amitriptyline hydrochloride (Gabantip-AT) exerts a positive effect on mood. TCAs are potent inhibitors of serotonin and norepinephrine reuptake. Tertiary amine TCAs, such as Amitriptyline hydrochloride (Gabantip-AT), are more potent inhibitors of serotonin reuptake than secondary amine TCAs, such as nortriptyline. TCAs also down-regulate cerebral cortical β-adrenergic receptors and sensitize post-synaptic serotonergic receptors with chronic use. The antidepressant effects of TCAs are thought to be due to an overall increase in serotonergic neurotransmission. TCAs also block histamine-H1 receptors, α1-adrenergic receptors and muscarinic receptors, which accounts for their sedative, hypotensive and anticholinergic effects (e.g. blurred vision, dry mouth, constipation, urinary retention), respectively. See toxicity section below for a complete listing of side effects. Amitriptyline hydrochloride (Gabantip-AT) may be used to treat depression, chronic pain (unlabeled use), irritable bowel syndrome (unlabeled use), diabetic neuropathy (unlabeled use), post-traumatic stress disorder (unlabeled use), and for migraine prophylaxis (unlabeled use).

Novo-Gabapentin (Gabantip-AT) (brand name Gabapentin (Gabantip-AT)) is a medication originally developed for the treatment of epilepsy. Presently, Gabapentin (Gabantip-AT) is widely used to relieve pain, especially neuropathic pain. Novo-Gabapentin (Gabantip-AT) is well tolerated in most patients, has a relatively mild side-effect profile, and passes through the body unmetabolized.

Therapeutic indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

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.

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

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.

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Oral

Epilepsy

Adult: Initially, 300 mg on the 1st day, 300 mg bid on the 2nd day and 300 mg tid on the 3rd day. Thereafter, may increase dose until effective antiepileptic control is achieved. Usual maintenance range: 0.9-3.6 g daily; daily dose to be taken in 3 equally divided doses and max dosing interval: 12 hr. Max: 4.8 g daily.

Child: ≥6 yr Initially, 10-15 mg/kg daily, titrated over a period of approx 3 days until effective antiepileptic control is achieved, usually w/in 25-35 mg/kg daily in 3 divided doses w/ max interval of 12 hr. Max: 50 mg/kg daily.

Renal impairment: Haemodialysis: Loading dose: 300-400 mg followed by 200-300 mg after each 4 hr of haemodialysis.

CrCl (ml/min)	Dosage Recommendation
<15	300 mg on alternate days to 300 mg daily.
15-29	300 mg on alternate days to 600 mg daily.
30-49	300-900 mg daily.
50-79	600-1,800 mg daily.

Oral

Neuropathic pain

Adult: Initially, 300 mg on the 1st day, 300 mg bid on the 2nd day and 300 mg tid on the 3rd day; alternatively, 900 mg daily in 3 divided doses. Dose may increase in increments of 300 mg every 2-3 days. Max: 3,600 mg daily.

Renal impairment: Haemodialysis: Loading dose: 300-400 mg followed by 200-300 mg after each 4 hr of haemodialysis.

CrCl (ml/min)	Dosage Recommendation
<15	300 mg on alternate days to 300 mg daily.
15-29	300 mg on alternate days to 600 mg daily.
30-49	300-900 mg daily.
50-79	600-1,800 mg daily.

Oral

Restless leg syndrome

Adult: As Gabapentin (Gabantip-AT) enacarbil: Modified-release preparation: Moderate to severe: 600 mg once daily at approx 5 pm.

Renal impairment: As Gabapentin (Gabantip-AT) enacarbil: Modified-release preparation:

Haemodialysis: Not recommended.

CrCl (ml/min)	Dosage Recommendation
<15	300 mg on alternate days.
15-29	300 mg daily.
30-59	Initially, 300 mg daily, increased to 600 mg daily, if needed.

Oral

Postherpetic neuralgia

Adult: As Gabapentin (Gabantip-AT) enacarbil: Modified-release preparation: Initially, 600 mg in the morning for 3 days, then increased to 600 mg bid.

Renal impairment: As Gabapentin (Gabantip-AT) enacarbil: Modified-release preparation:

Haemodialysis: 300 mg after each dialysis session, may increase to 600 mg if needed.

CrCl (ml/min)	Dosage Recommendation
<15	300 mg in the morning on alternate days, may increase to 300 mg daily in the morning.
15-29	300 mg in the morning on days 1 and 3 followed by 300 mg daily in the morning, may increase to 300 mg bid.
30-59	300 mg in the morning for the 1st 3 days followed by 300 mg bid, may increase to 600 mg bid.

Amitriptyline (Gabantip-AT) is a tricyclic antidepressant. Amitriptyline (Gabantip-AT) affects chemicals in the brain that may be unbalanced in people with depression.

Amitriptyline (Gabantip-AT) is used to treat symptoms of depression.

Amitriptyline (Gabantip-AT) may also be used for purposes not listed in this medication guide.

Amitriptyline hydrochloride (Gabantip-AT) (Amitriptyline hydrochloride (Gabantip-AT)) is a tricyclic antidepressant.

Amitriptyline hydrochloride (Gabantip-AT) affects chemicals in the brain that may be unbalanced in people with depression.

Amitriptyline hydrochloride (Gabantip-AT) is used to treat symptoms of depression.

Gabapentin (Gabantip-AT) is used to help control partial seizures (convulsions) in the treatment of epilepsy. Gabapentin (Gabantip-AT) cannot cure epilepsy and will only work to control seizures for as long as you continue to take it.

Gabapentin (Gabantip-AT) is also used in adults to manage a condition called postherpetic neuralgia, which is pain that occurs after shingles.

Gabapentin (Gabantip-AT) works in the brain to prevent seizures and relieve pain for certain conditions in the nervous system. It is not used for routine pain caused by minor injuries or arthritis. Gabapentin (Gabantip-AT) is an anticonvulsant.

Gabapentin (Gabantip-AT) is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, Gabapentin (Gabantip-AT) is used in certain patients with the following medical condition:

Diabetic peripheral neuropathy.

Dosage (Posology) and method of administration

Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance.

Initial Dosage For Adults

For outpatients 75 mg of Amitriptyline (Gabantip-AT) HCl a day in divided doses is usually satisfactory. If necessary, this may be increased to a total of 150 mg per day. Increases are made preferably in the late afternoon and/or bedtime doses. A sedative effect may be apparent before the antidepressant effect is noted, but an adequate therapeutic effect may take as long as 30 days to develop.

An alternate method of initiating therapy in outpatients is to begin with 50 to 100 mg Amitriptyline (Gabantip-AT) HCl at bedtime. This may be increased by 25 or 50 mg as necessary in the bedtime dose to a total of 150 mg per day.

Hospitalized patients may require 100 mg a day initially. This can be increased gradually to 200 mg a day if necessary. A small number of hospitalized patients may need as much as 300 mg a day.

Adolescent And Elderly Patients

In general, lower dosages are recommended for these patients. Ten mg 3 times a day with 20 mg at bedtime may be satisfactory in adolescent and elderly patients who do not tolerate higher dosages.

Maintenance

The usual maintenance dosage of Amitriptyline (Gabantip-AT) HCl is 50 to 100 mg per day. In some patients 40 mg per day is sufficient. For maintenance therapy the total daily dosage may be given in a single dose preferably at bedtime. When satisfactory improvement has been reached, dosage should be reduced to the lowest amount that will maintain relief of symptoms. It is appropriate to continue maintenance therapy 3 months or longer to lessen the possibility of relapse.

Usage In Pediatric Patients

In view of the lack of experience with the use of this drug in pediatric patients, it is not recommended at the present time for patients under 12 years of age.

Plasma Levels

Because of the wide variation in the absorption and distribution of tricyclic antidepressants in body fluids, it is difficult to directly correlate plasma levels and therapeutic effect. However, determination of plasma levels may be useful in identifying patients who appear to have toxic effects and may have excessively high levels, or those in whom lack of absorption or noncompliance is suspected. Because of increased intestinal transit time and decreased hepatic metabolism in elderly patients, plasma levels are generally higher for a given oral dose of Amitriptyline (Gabantip-AT) hydrochloride than in younger patients.

Elderly patients should be monitored carefully and quantitative serum levels obtained as clinically appropriate. Adjustment in dosage should be made according to the patient's clinical response and not on the basis of plasma levels.**

How supplied

10 mg tablets are blue, round, unscored, film coated tablets, debossed “2101” on one side and debossed “V” on the reverse side. They are supplied as follows:

Bottles of 30: NDC 0603-2212-16

Bottles of 90: NDC 0603-2212-02

Bottles of 100: NDC 0603-2212-21

Bottles of 1000: NDC 0603-2212-32

25 mg tablets are yellow, round, unscored, film coated tablets, debossed “2102” on one side and debossed “V” on the reverse side. They are supplied as follows:

Bottles of 90: NDC 0603-2213-02

Bottles of 100: NDC 0603-2213-21

Bottles of 1000: NDC 0603-2213-32

Bottles of 2500: NDC 0603-2213-30

50 mg tablets are beige, round, unscored, film coated tablets, debossed “2103” on one side and debossed “V” on the reverse side. They are supplied as follows:

Bottles of 100: NDC 0603-2214-21

Bottles of 1000: NDC 0603-2214-32

75 mg tablets are orange, round, unscored, film coated tablets, debossed “2104” and “V”. They are supplied as follows:

Bottles of 100: NDC 0603-2215-21

Bottles of 300: NDC 0603-2215-25

100 mg tablets are mauve, round, unscored, film coated tablets, debossed “2105” and “V”. They are supplied as follows:

Bottles of 100: NDC 0603-2216-21

Bottles of 300: NDC 0603-2216-25

150 mg tablets are blue, capsule shaped, unscored, film coated tablets, debossed “2106” on one side and debossed “V” on the reverse side. They are supplied as follows:

Bottles of 100: NDC 0603-2217-21

Bottles of 300: NDC 0603-2217-25

Storage And Handling

Storage

Store in a well-closed container. Store at 20°-25°C (68°-77°F). In addition, Amitriptyline (Gabantip-AT) tablets must be protected from light and stored in a well-closed, light-resistant container

REFERENCES

Ayd FJ Jr: Amitriptyline (Gabantip-AT) therapy for depressive reactions. Psychosomatics 1960;1:320–325.

Diamond S: Human metabolizer of Amitriptyline (Gabantip-AT) tagged with carbon 14. Curr Ther Res, Mar 1965, pp 170–175.

Dorfman W: Clinical experiences with Amitriptyline (Gabantip-AT): A preliminary report. Psychosomatics 1960;1:153– 155.

Fallette JM, Stasney CR, Mintz AA: Amitriptyline (Gabantip-AT) poisoning treated with physostigmine. South Med J 1970;63:1492–1493.

Hollister LE, Overall JE, Johnson M, et al: Controlled comparison of Amitriptyline (Gabantip-AT), imipramine and placebo in hospitalized depressed patients. J Nerv Ment Dis 1964;139:370–375.

Hordern A, Burt CG, Holt NF: Depressive states: A pharmacotherapeutic study, Springfield study. Springfield, Ill, Charles C. Thomas, 1965. Jenike MA: Treatment of Affective Illness in the Elderly with Drugs and Electroconvulsive Therapy. J Geriatr Psychiatry 1989; 22(1):77–112.

Klerman GL, Cole JO: Clinical pharmacology of imipramine and related antidepressant compounds. Int J Psychiatry 1976;3:267–304.

Liu B, Anderson G, Mittman N, et al: Use of selective serotonin-reuptake inhibitors or tricyclic antidepressants and risk of hip fractures in elderly people. Lancet 1998; 351(9112):1303–1307.

McConaghy N, Joffe AD, Kingston WA, et al: Correlation of clinical features of depressed out-patients with response to Amitriptyline (Gabantip-AT) and protriptyline. Br J Psychiatry 1968;114:103–106.

McDonald IM, Perkins M, Marjerrison G, et al: A controlled comparison of Amitriptyline (Gabantip-AT) and electroconvulsive therapy in the treatment of depression. Am J Psychiatry 1966;122:1427–1431.

Slovis T, Ott J, Teitelbaum D, et al: Physostigmine therapy in acute tricyclic antidepressant poisoning. Clin Toxicol 1971;4:451–459.

Symposium on depression with special studies of a new antidepressant, Amitriptyline (Gabantip-AT). Dis Nerv Syst, (Sect 2) May 1961, pp 5–56.

*Based on a maximum recommended Amitriptyline (Gabantip-AT) dose of 150 mg/day or 3 mg/kg/day for a 50 kg patient.

**Hollister LE: Monitoring Tricyclic Antidepressant Plasma Concentrations. JAMA 1979; 241(23):2530–2533.

Amitriptyline (Gabantip-AT) 25 mg tablets are yellow, round, unscored, film coated tablets, debossed “2102” on one side and debossed “V” on the reverse side. They are supplied as follows: Bottles of 100: NDC 69874-422-10

Manufactured by: Qualitest Pharmaceuticals/Vintage Pharmaceuticals, Huntsville, AL 35811. Manufactured for: Thompson Medical Solutions, Birmingham, AL 35242. Revised: Apr 2016

Usual Adult Dose of Amitriptyline hydrochloride (Gabantip-AT) for Depression:

Outpatients:

Usual dose: 75 mg orally per day in divided doses; this may be increased to a total of 150 mg per day if needed

Alternate dose: 40 to 100 mg orally as a single dose at bedtime; this may be increased by 25 or 50 mg as needed at bedtime to a total of 150 mg per day

Maximum dose: 150 mg orally per day

Inpatients:

Initial dose: 100 mg orally per day

Maintenance dose: 40 to 100 mg orally as a single dose at bedtime

Maximum dose: 300 mg orally per day

Comments:

-Dosage should be reduced to the lowest amount that will maintain relief of symptoms, when satisfactory improvement has been obtained.

-Dose increases should preferably be made in the late afternoon or at bedtime due to the sedative effect.

-The full therapeutic effect may take as long as 30 days to develop.

-Maintenance therapy should be continued for 3 months or longer to lessen the possibility of relapse.

Use: Relief of symptoms of depression

Usual Geriatric Dose of Amitriptyline hydrochloride (Gabantip-AT) for Depression:

10 mg orally 3 times a day with 20 mg at bedtime

Comments:

-The full therapeutic effect may take as long as 30 days to develop.

-Elderly patients should be monitored carefully and serum levels obtained as clinically appropriate.

-Dose adjustments should be made according to clinical response.

Use: Relief of symptoms of depression

Usual Pediatric Dose for Depression:

12 years or older:

10 mg orally 3 times a day with 20 mg at bedtime

Use: Relief of symptoms of depression

Postherpetic Neuralgia

Do not use Gabapentin (Gabantip-AT) interchangeably with other Gabapentin (Gabantip-AT) products.

Titrate Gabapentin (Gabantip-AT) to an 1800 mg dose taken orally once daily with the evening meal. Gabapentin (Gabantip-AT) tablets should be swallowed whole. Do not split, crush, or chew the tablets.

If Gabapentin (Gabantip-AT) dose is reduced, discontinued, or substituted with an alternative medication, this should be done gradually over a minimum of one week or longer (at the discretion of the prescriber).

In adults with postherpetic neuralgia, Gabapentin (Gabantip-AT) therapy should be initiated and titrated as follows:

Patients with Renal Impairment

In patients with stable renal function, creatinine clearance (CCr) can be reasonably well estimated using the equation of Cockcroft and Gault:

For females CCr=(0.85)(140-age)(weight)/[(72)(SCr)]

For males CCr=(140-age)(weight)/[(72)(SCr)]

where age is in years, weight is in kilograms and SCr is serum creatinine in mg/dL.

The dose of Gabapentin (Gabantip-AT) should be adjusted in patients with reduced renal function, according to Table 2. Patients with reduced renal function must initiate Gabapentin (Gabantip-AT) at a daily dose of 300 mg. Gabapentin (Gabantip-AT) should be titrated following the schedule outlined in Table 1. Daily dosing in patients with reduced renal function must be individualized based on tolerability and desired clinical benefit.

Contraindications

Amitriptyline (Gabantip-AT) hydrochloride is contraindicated in patients who have shown prior hypersensitivity to it.

It should not be given concomitantly with monoamine oxidase inhibitors. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. When it is desired to replace a monoamine oxidase inhibitor with Amitriptyline (Gabantip-AT) hydrochloride, a minimum of 14 days should be allowed to elapse after the former is discontinued. Amitriptyline (Gabantip-AT) hydrochloride should then be initiated cautiously with a gradual increase in dosage until optimum response is achieved.

Amitriptyline (Gabantip-AT) hydrochloride should not be given with Cisapride due to the potential for increased QT interval and increased risk for arrhythmia.

This drug is not recommended for use during the acute recovery phase following myocardial infarction.

Amitriptyline hydrochloride (Gabantip-AT) is contraindicated in patients who have shown prior hypersensitivity to it.

It should not be given concomitantly with monoamine oxidase inhibitors. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. When it is desired to replace a monoamine oxidase inhibitor with Amitriptyline hydrochloride (Gabantip-AT), a minimum of 14 days should be allowed to elapse after the former is discontinued. Amitriptyline hydrochloride (Gabantip-AT) should then be initiated cautiously with a gradual increase in dosage until optimum response is achieved.

Amitriptyline hydrochloride (Gabantip-AT) should not be given with Cisapride due to the potential for increased QT interval and increased risk for arrhythmia.

This drug is not recommended for use during the acute recovery phase following myocardial infarction.

You should not use this medication if you are allergic to Gabapentin (Gabantip-AT).

Before taking Gabapentin (Gabantip-AT), tell your doctor if you have kidney, liver, or heart disease.

You may have thoughts about suicide while taking Gabapentin (Gabantip-AT). Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, depression, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Do not stop taking Gabapentin (Gabantip-AT) for seizures without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using Gabapentin (Gabantip-AT) suddenly. You may need to use less and less before you stop the medication completely.

Contact your doctor if your seizures get worse or you have them more often while taking Gabapentin (Gabantip-AT).

Wear a medical alert tag or carry an ID card stating that you take Gabapentin (Gabantip-AT). Any doctor, dentist, or emergency medical care provider who treats you should know that you take seizure medication.

Special warnings and precautions for use

Use Amitriptyline (Gabantip-AT) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Amitriptyline (Gabantip-AT) comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Amitriptyline (Gabantip-AT) refilled.
Amitriptyline (Gabantip-AT) may be taken with food or on an empty stomach.
Amitriptyline (Gabantip-AT) may take up to 30 days to control symptoms of depression. Continue to use Amitriptyline (Gabantip-AT) even if you feel well. Do not miss any doses.
If you miss a dose of Amitriptyline (Gabantip-AT), 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 Amitriptyline (Gabantip-AT).

Use Amitriptyline hydrochloride (Gabantip-AT) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Amitriptyline hydrochloride (Gabantip-AT) comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Amitriptyline hydrochloride (Gabantip-AT) refilled.
Amitriptyline hydrochloride (Gabantip-AT) may be taken with food or on an empty stomach.
Amitriptyline hydrochloride (Gabantip-AT) may take up to 30 days to control symptoms of depression. Continue to use Amitriptyline hydrochloride (Gabantip-AT) even if you feel well. Do not miss any doses.
If you miss a dose of Amitriptyline hydrochloride (Gabantip-AT), 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 Amitriptyline hydrochloride (Gabantip-AT).

Use Gabapentin (Gabantip-AT) capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Gabapentin (Gabantip-AT) capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Gabapentin (Gabantip-AT) capsules refilled.
Take Gabapentin (Gabantip-AT) capsules by mouth with or without food.
Swallow Gabapentin (Gabantip-AT) capsules whole with plenty of water. Do not break, crush, or chew before swallowing.
Do not take an antacid containing aluminum or magnesium within 2 hours before you take Gabapentin (Gabantip-AT) capsules.
Do not suddenly stop taking Gabapentin (Gabantip-AT) capsules. Patients taking Gabapentin (Gabantip-AT) capsules to prevent seizures may have an increased risk of seizures if the medicine is suddenly stopped. If you need to stop Gabapentin (Gabantip-AT) capsules or add a new medicine, your doctor will gradually lower your dose.
If you miss a dose of Gabapentin (Gabantip-AT) capsules, 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 Gabapentin (Gabantip-AT) capsules.

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

This medication is used to treat mental/mood problems such as depression. It may help improve mood and feelings of well-being, relieve anxiety and tension, help you sleep better, and increase your energy level. This medication belongs to a class of medications called tricyclic antidepressants. It works by affecting the balance of certain natural chemicals (neurotransmitters such as serotonin) in the brain.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat nerve pain (such as peripheral neuropathy, postherpetic neuralgia), eating disorder (bulimia), other mental/mood problems (such as anxiety, panic disorder), or to prevent migraine headaches.

How to use Amitriptyline (Gabantip-AT)

Read the Medication Guide provided by your pharmacist before you start taking Amitriptyline (Gabantip-AT) and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth, usually 1 to 4 times daily or as directed by your doctor. If you take it only once a day, take it at bedtime to help reduce daytime sleepiness. The dosage is based on your medical condition and response to treatment.

To reduce your risk of side effects (such as drowsiness, dry mouth, dizziness), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

It is important to continue taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as mood swings, headache, tiredness, and sleep change. To prevent these symptoms while you are stopping treatment with this drug, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details. Report any new or worsening symptoms right away.

This medication may not work right away. You may see some benefit within a week. However, it may take up to 4 weeks before you feel the full effect.

Tell your doctor if your condition persists or worsens (such as your feelings of sadness get worse, or you have thoughts of suicide).

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

Use: Labeled Indications

Major depressive disorder (unipolar): Treatment of unipolar major depressive disorder

Off Label Uses

Chronic fatigue syndrome related sleep disturbances and pain

Based on the NICE guidelines for chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy), Amitriptyline hydrochloride (Gabantip-AT) is suggested for patients with chronic fatigue syndrome and poor sleep. In addition, based on the Health Canada myalgic encephalomyelitis/chronic fatigue syndrome diagnostic and treatment protocol, Amitriptyline hydrochloride (Gabantip-AT) is also suggested for chronic fatigue syndrome related pain.

EFNS guidelines on the clinical management of amyotrophic lateral sclerosis (ALS) recommend Amitriptyline hydrochloride (Gabantip-AT) as good clinical practice in the management of sialorrhea, particularly in patients also experiencing emotional lability.

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

Gabapentin (Gabantip-AT) is used with other medications to prevent and control seizures. It is also used to relieve nerve pain following shingles (a painful rash due to herpes zoster infection) in adults. Gabapentin (Gabantip-AT) is known as an anticonvulsant or antiepileptic drug.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Gabapentin (Gabantip-AT) may also be used to treat other nerve pain conditions (such as diabetic neuropathy, peripheral neuropathy, trigeminal neuralgia) and restless legs syndrome.

How to use Gabapentin (Gabantip-AT)

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking Gabapentin (Gabantip-AT) and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor. Dosage is based on your medical condition and response to treatment. For children, the dosage is also based on weight.

If you are taking the tablets and your doctor directs you to split the tablet in half, take the other half-tablet at your next scheduled dose. Discard half tablets if not used within several days of splitting them. If you are taking the capsules, swallow them whole with plenty of water.

It is very important to follow your doctor's dosing instructions exactly. During the first few days of treatment, your doctor may gradually increase your dose so your body can adjust to the medication. To minimize side effects, take the very first dose at bedtime.

Take this medication regularly to get the most benefit from it. This drug works best when the amount of medicine in your body is kept at a constant level. Therefore, take Gabapentin (Gabantip-AT) at evenly spaced intervals at the same time(s) each day. If you are taking this medication 3 times a day to control seizures, do not let more than 12 hours pass between doses because your seizures may increase.

Do not take this medication more often or increase your dose without consulting your doctor. Your condition will not improve any faster and the risk of serious side effects may increase.

Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.

Antacids containing aluminum or magnesium may interfere with the absorption of this medication. Therefore, if you are also taking an antacid, it is best to take Gabapentin (Gabantip-AT) at least 2 hours after taking the antacid.

Different forms of Gabapentin (Gabantip-AT) (such as immediate-release, sustained-release, enacarbil sustained-release) are absorbed in the body differently. Do not switch from one form to the other without consulting your doctor.

Tell your doctor if your condition does not improve or if it worsens.

Interaction with other medicinal products and other forms of interaction

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: arbutamine, disulfiram, thyroid supplements, other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen, "blood thinners" such as warfarin), anticholinergic drugs (such as benztropine, belladonna alkaloids), certain drugs for high blood pressure (drugs that work in the brain such as clonidine, guanabenz, reserpine).

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication.

Other medications can affect the removal of Amitriptyline (Gabantip-AT) from your body, thereby affecting how Amitriptyline (Gabantip-AT) works. These drugs include cimetidine, terbinafine, drugs to treat irregular heart rate (such as quinidine/propafenone/flecainide), antidepressants (such as SSRIs including paroxetine/fluoxetine/fluvoxamine). This is not a complete list.

Many drugs besides Amitriptyline (Gabantip-AT) may affect the heart rhythm (QT prolongation in the EKG), including amiodarone, cisapride, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others. Therefore, before using Amitriptyline (Gabantip-AT), report all medications you are currently using to your doctor or pharmacist.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness, including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain decongestants or ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Amitriptyline (Gabantip-AT) is very similar to nortriptyline. Do not use medications containing nortriptyline while using Amitriptyline (Gabantip-AT).

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 to 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 (TCAs) 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 coadministration of TCAs with any of 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 coadministered with another drug known to be an inhibitor of P450 2D6.

Monoamine Oxidase Inhibitors

Hyperpyrexia has been reported when Amitriptyline hydrochloride (Gabantip-AT) is administered with anticholinergic agents or with neuroleptic drugs, particularly during hot weather.

Paralytic ileus may occur in patients taking tricyclic antidepressants in combination with anticholinergic-type drugs.

Cimetidine is reported to reduce hepatic metabolism of certain tricyclic antidepressants, thereby delaying elimination and increasing steady-state concentrations of these drugs. Clinically significant effects have been reported with the tricyclic antidepressants when used concomitantly with cimetidine. Increases in plasma levels of tricyclic antidepressants, and in the frequency and severity of side effects, particularly anticholinergic, have been reported when cimetidine was added to the drug regimen. Discontinuation of cimetidine in well-controlled patients receiving tricyclic antidepressants and cimetidine may decrease the plasma levels and efficacy of the antidepressants.

Caution is advised if patients receive large doses of ethchlorvynol concurrently. Transient delirium has been reported in patients who were treated with one gram of ethchlorvynol and 75 to 150 mg of Amitriptyline hydrochloride (Gabantip-AT).

Other Antiepileptic Drugs

Gabapentin (Gabantip-AT) is not appreciably metabolized nor does it interfere with the metabolism of commonly coadministered antiepileptic drugs.

Opioids

Hydrocodone

Coadministration of Gabapentin (Gabantip-AT) with hydrocodone decreases hydrocodone exposure. The potential for alteration in hydrocodone exposure and effect should be considered when Gabapentin (Gabantip-AT) is started or discontinued in a patient taking hydrocodone.

Morphine

When Gabapentin (Gabantip-AT) is administered with morphine, patients should be observed for signs of central nervous system (CNS) depression, such as somnolence, sedation and respiratory depression.

Maalox dipstick test for urinary protein when Gabapentin (Gabantip-AT) was added to other antiepileptic drugs, the more specific sulfosalicylic acid precipitation procedure is recommended to determine the presence of urine protein.

Drug Abuse And Dependence

Controlled Substance

Gabapentin (Gabantip-AT) is not a scheduled drug.

Abuse

Gabapentin (Gabantip-AT) does not exhibit affinity for benzodiazepine, opiate (mu, delta or kappa), or cannabinoid 1 receptor sites. A small number of postmarketing cases report Gabapentin (Gabantip-AT) misuse and abuse. These individuals were taking higher than recommended doses of Gabapentin (Gabantip-AT) for unapproved uses. Most of the individuals described in these reports had a history of poly-substance abuse or used Gabapentin (Gabantip-AT) to relieve symptoms of withdrawal from other substances. When prescribing Gabapentin (Gabantip-AT) carefully evaluate patients for a history of drug abuse and observe them for signs and symptoms of Gabapentin (Gabantip-AT) misuse or abuse (e.g., development of tolerance, self-dose escalation, and drug-seeking behavior).

Dependence

There are rare postmarketing reports of individuals experiencing withdrawal symptoms shortly after discontinuing higher than recommended doses of Gabapentin (Gabantip-AT) used to treat illnesses for which the drug is not approved. Such symptoms included agitation, disorientation and confusion after suddenly discontinuing Gabapentin (Gabantip-AT) that resolved after restarting Gabapentin (Gabantip-AT). Most of these individuals had a history of poly-substance abuse or used Gabapentin (Gabantip-AT) to relieve symptoms of withdrawal from other substances. The dependence and abuse potential of Gabapentin (Gabantip-AT) has not been evaluated in human studies.

Undesirable effects

Within each category the following adverse reactions are listed in order of decreasing severity. Included in the listing are a few adverse reactions which have not been reported with this specific drug. However, pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when Amitriptyline (Gabantip-AT) is administered.

Cardiovascular: Myocardial infarction; stroke; nonspecific ECG changes and changes in AV conduction; heart block; arrhythmias; hypotension, particularly orthostatic hypotension; syncope; hypertension; tachycardia; palpitation.

CNS and Neuromuscular: Coma; seizures; hallucinations; delusion; confusional states; disorientation; incoordination; ataxia; tremors; peripheral neuropathy; numbness, tingling and paresthesias of the extremities; extrapyramidal symptoms including abnormal involuntary movements and tardive dyskinesia; dysarthria; disturbed concentration; excitement; anxiety; insomnia; restlessness; nightmares; drowsiness; dizziness; weakness; fatigue; headache; syndrome of inappropriate ADH (antidiuretic hormone) secretion; tinnitus; alteration in EEG patterns.

Anticholinergic: Paralytic ileus; hyperpyrexia; urinary retention; dilatation of the urinary tract; constipation; blurred vision, disturbance of accommodation, increased ocular pressure, mydriasis; dry mouth.

Allergic: Skin rash; urticaria; photosensitization; edema of face and tongue.

Hematologic: Bone marrow depression including agranulocytosis, leukopenia, thrombocytopenia; purpura; eosinophilia.

Gastrointestinal: Rarely hepatitis (including altered liver function and jaundice); nausea; epigastric distress; vomiting; anorexia; stomatitis; peculiar taste; diarrhea; parotid swelling; black tongue.

Endocrine: Testicular swelling and gynecomastia in the male; breast enlargement and galactorrhea in the female; increased or decreased libido; impotence; elevation and lowering of blood sugar levels.

Other: Alopecia; edema; weight gain or loss; urinary frequency; increased perspiration.

Withdrawal Symptoms: After prolonged administration, abrupt cessation of treatment may produce nausea, headache, and malaise. Gradual dosage reductions have been reported to produce, within two weeks, transient symptoms including irritability, restlessness, and dream and sleep disturbance.

These symptoms are not indicative of addiction. Rare instances have been reported of mania or hypomania occurring within 2 to 7 days following cessation of chronic therapy with tricyclic antidepressants.

Causal Relationship Unknown: Other reactions, reported under circumstances where a causal relationship could not be established, are listed to serve as alerting information to physicians.

Body as a Whole: Lupus-like syndrome (migratory arthritis, positive ANA and rheumatoid factor).

Digestive: Hepatic failure, ageusia.

Postmarketing Adverse Events: A syndrome resembling neuroleptic malignant syndrome (NMS) has been very rarely reported after starting or increasing the dose of Amitriptyline (Gabantip-AT) hydrochloride, with and without concomitant medications known to cause NMS. Symptoms have included muscle rigidity, fever, mental status changes, diaphoresis, tachycardia, and tremor.

Very rare cases of serotonin syndrome (SS) have been reported with Amitriptyline (Gabantip-AT) hydrochloride in combination with other drugs that have a recognized association with SS.

Very rare cases of cardiomyopathy have been reported with Amitriptyline (Gabantip-AT).

Within each category the following adverse reactions are listed in order of decreasing severity. Included in the listing are a few adverse reactions which have not been reported with this specific drug. However, pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when Amitriptyline hydrochloride (Gabantip-AT) is administered.