Composition

GABAPIN 100
Each tablet contains:
Gabapentin USP 100 mg
Colour: Titanium Dioxide
Excipients: Q.S.
GABAPIN 300
Each capsule contains:
Gabapentin USP 300 mg
Colour: Titanium Dioxide
Excipients: Q.S.
GABAPIN 400
Each capsule contains:
Gabapentin USP 400 mg
Colour: Titanium Dioxide
Excipients: Q.S.
GABAPIN 600
Each tablet contains:
Gabapentin USP 600 mg
Colour: Titanium Dioxide
Excipients: Q.S.
GABAPIN 800
Each tablet contains:
Gabapentin USP 800 mg
Colour: Titanium Dioxide
Excipients: Q.S.

Description

  • The active ingredient in GABAPIN tablets and capsules is gabapentin, which is intended for oral use in the treatment of postherpetic neuralgia in adults and adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.
  • Gabapentin is basically an anticonvulsant. It also alleviates neuropathic pain. Chemically gabapentin is described as 1-(Aminomethyl)cyclohexaneacetic acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24.

Clinical Pharmacology

Pharmacodynamics

  • Gabapentin is structurally related to the neurotransmitter gamma-aminobutyric acid (GABA) but it does not modify GABAA or GABAB radioligand binding, it is not converted metabolically into GABA or a GABA agonist, and it is not an inhibitor of GABA uptake or degradation. It acts as a neuromodulator by selectively binding to alpha2-delta subunit protein of the neuronal calcium channel in various regions of the brain and the superficial dorsal horn of the spinal cord. The mechanism by which gabapentin exerts its analgesic action is unknown, but in animal models of analgesia, gabapentin prevents allodynia (pain-related behavior in response to a normally innocuous stimulus) and hyperalgesia (exaggerated response to painful stimuli). In particular, gabapentin prevents pain-related responses in several models of neuropathic pain in rats and mice. Gabapentin also decreases pain-related responses after peripheral inflammation.

Pharmacokinetics

  • Gabapentin bioavailability is not dose proportional; i.e., as dose is increased, bioavailability decreases. Food has only a slight effect on the rate and extent of absorption of gabapentin. Less than 3% of gabapentin circulates bound to plasma protein. The apparent volume of distribution of gabapentin after 150 mg intravenous administration is 58 ± 6 L (Mean ± SD). Gabapentin is eliminated from the systemic circulation by renal excretion as unchanged drug. Gabapentin is not appreciably metabolized in humans. Gabapentin elimination half-life is 5 to 7 hours and is unaltered by dose or following multiple dosing.

Indications

GABAPIN is indicated for the:

  • Postherpetic neuralgia in adults
  • Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.

Contraindications

GABAPIN is contraindicated if patient have hypersensitivity to gabapentin, or to any ingredient in the formulation.

Dosage And Administration

GABAPIN is given orally with or without food. If gabapentin dose is reduced, discontinued or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).

Postherpetic Neuralgia

  • Dose can be titrated up as needed to a dose of 1800 mg/day
  • Day 1: Single 300 mg dose
  • Day 2: 600 mg/day (i.e., 300 mg two times a day)
  • Day 3: 900 mg/day (i.e., 300 mg three times a day)

Epilepsy with Partial Onset Seizures (2.2)

  • Patients 12 years of age and older: starting dose is 300 mg three times daily; may be titrated up to 600 mg three times daily.
  • Patients 3 to 11 years of age: starting dose range is 10 to 15 mg/kg/day, given in three divided doses; recommended dose in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses; the recommended dose in patients 5 to 11 years of age is 25 to 35 mg/kg/day, given in three divided doses. The recommended dose is reached by upward titration over a period of approximately 3 days.

Dose should be adjusted in patients with reduced renal function

Use in Special Population

Pediatric Use

  • Use of gabapentin in pediatric patients aged less than 3 years is not recommended.

Geriatric Use

  • Gabapentin should be used cautiously in elderly subjects.
  • Gabapentin is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.
  • Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.

Use in Pregnancy and Lactation

  • Use of GABAPIN is not recommended.
  • Pregnancy Category C.

Dosage in Renal Impairment

  • Dosage adjustment in patients 12 years of age and older with renal impairment or undergoing hemodialysis is recommended, as follows (see dosing recommendations above for effective doses in each indication):
Renal Function [Creatinine Clearance] (ml/min) Total daily dose range [mg/day] Dose regimen [mg]
≥60 900 to 3600 300 TID; 400 TID; 600 TID; 800 TID; 1200 TID
≥30-59 400 to 1400 200 BID; 300 BID; 400 BID; 500 BID; 700 BID
≥15-29 200 to 700 200 QD; 300 QD; 400 QD 500; QD; 700 QD
15a 100 to 300 100 QD; 125 QD; 150 QD; 200 QD; 300 QD
Post-Hemodialysis Supplemental Dose (mg)b
Hemodialysis 125b; 150b; 200b; 250b; 350b
  • TID = Three times a day; BID = Two times a day; QD = Single daily dose
  • a for patients with creatinine clearance < 15 mL/min, reduce daily dose in proportion to creatinine clearance(e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive).
  • b for Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.

Dosage in Hepatic Impairment

  • Dosage adjustment of gabapentin is not needed in mild to moderate hepatic impairment. It is not recommended for use in severe hepatic impairment.

Warnings And Precautions

  • Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan hypersensitivity): discontinue if alternative etiology is not established.
  • Anaphylaxis and Angioedema: discontinue and evaluate patient immediately.
  • Driving Impairment; Somnolence/Sedation and Dizziness: warn patientsnot to drive until they have gained sufficient experience to assess whether their ability to drive or operate heavy machinery will be impaired.
  • Increased seizure frequency may occur in patients with seizure disorders if gabapentin is abruptly discontinued.
  • Suicidal Behavior and Ideation: monitor for suicidal thoughts/behavior.
  • Neuropsychiatric Adverse Reactions in Children 3-12 Years of Age: monitor for such events.

Carcinogenesis, Mutagenesis, Impairment of Fertility

  • A statistically significant increase in the incidence of pancreatic acinar cell adenomas and carcinomas was found in male rats receiving the high dose of gabapentin. Gabapentin did not demonstrate mutagenic or genotoxic potential in vitro and in vivo assays. No adverse effects on fertility or reproduction were observed in rats.

Drug Interactions

  • Coadministration with naproxen, hydrocodon, morphine can leads to increased bioavaibility of gabapentin.
  • Cimetidine and probenecid coadministration can alter the renal excretion of gabapentin.
  • Antacid like aluminum hydroxide and magnesium hydroxide can reduce the bioavailability of gabapentin.
  • The peak plasma concentration of norethindrone can increase when orally coadministered with gabapentin.
  • Gabapentin is not appreciably metabolized nor does it interfere with the metabolism of commonly coadministered antiepileptic drugs such as phenytoin, carbamazepine, valproic acid and phenobarbitone.

Adverse Effects

Adverse effects to gabapentin are as mentioned below:

The most commonly reported adverse events associated with the use of gabapentin in adults are dizziness, somnolence, and peripheral edema.

Other important side effects, system-wise, are mentioned below:

  • Body as a Whole: asthenia, malaise, face edema, allergy, generalized edema.
  • Cardiovascular System: hypertension, hypotension, palpitation, tachycardia, murmur.
  • Digestive System: anorexia, flatulence, gingivitis, glossitis, stomatitis.
  • Endocrine System: hyperthyroid, hypothyroid, goiter, hypoestrogen, ovarian failure, epididymitis, swollen testicle, cushingoid appearance.
  • Hematologic and Lymphatic System: purpura; thrombocytopenia.
  • Musculoskeletal System: arthralgia, tendinitis, arthritis, joint stiffness, joint swelling.
  • Nervous System: vertigo, hyperkinesia, paresthesia, ataxia, tremors; dystonia, decreased or absent reflexes, increased reflexes, anxiety, hostility, syncope, dreaming abnormal, aphasia, hypoesthesia, intracranial hemorrhage, hypotonia, dysesthesia.
  • Psychiatric: exacerbation of psychoses, euphoria, agitation, paranoia.
  • Respiratory System: pneumonia, epistaxis, dyspnea, apnea.
  • Dermatological: alopecia, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea.
  • Urogenital System: hematuria, dysuria, urination frequency, cystitis, urinary retention, urinary incontinence, vaginal hemorrhage, amenorrhea, dysmenorrhea, menorrhagia, breast cancer, unable to climax, ejaculation abnormal.
  • Special Senses: abnormal vision, hearing loss, earache, tinnitus, unusual taste.

Overdose

Symptoms

  • Acute oral overdoses of gabapentin up to 49 grams have been reported. In these cases, double vision, slurred speech, drowsiness, lethargy and diarrhea were observed.

Management

  • There is no specific antidote. Patients recovered with supportive care. Gabapentin can be removed by hemodialysis. Although hemodialysis has not been performed in the few overdose cases reported, it may be indicated by the patient's clinical state or in patients with significant renal impairment.

Presentation

  • GABAPIN 400, 300 capsules
  • GABAPIN 100, 600, 800 tablets

Storage

  • Store in a cool and dry place at below 30̊C. Protect from light and moisture.
  • Keep all medicines away from the reach of children.

Composition

GABAPIN NT 400
Each film-coated tablet contains:
Gabapentin USP 400 mg
Nortriptyline Hydrochloride IP equivalent to
Nortriptyline 10 mg
Colour: Titanium Dioxide
Excipients: Q.S.
GABAPIN NT 100
Each film-coated tablet contains:
Gabapentin USP 100 mg
Nortriptyline Hydrochloride IP equivalent to
Nortriptyline 10 mg
Colour: Titanium Dioxide
Excipients: Q.S.

Description

  • GABAPIN NT is a fixed-dose combination product containing gabapentin and nortriptyline. It is intended for oral use in neuropathic pain.
  • Gabapentin is basically an anticonvulsant. It also alleviates neuropathic pain. Chemically gabapentin is described as 1-(Aminomethyl)cyclohexaneacetic acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24.
  • Nortriptyline hydrochloride is a tricyclic antidepressant. It is a metabolite of amitriptyline which is also used as an antidepressant. The chemical name of nortriptyline hydrochloride is 1-Propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochlori-de. Its molecular formula is C19H21N•HCL and molecular weight 299.84.

Clinical Pharmacology

Pharmacodynamics

Gabapentin

  • Gabapentin is structurally related to the neurotransmitter gamma-aminobutyric acid (GABA) but it does not modify GABAA or GABAB radioligand binding, it is not converted metabolically into GABA or a GABA agonist, and it is not an inhibitor of GABA uptake or degradation. It acts as a neuromodulator by selectively binding to alpha2-delta subunit protein of the neuronal calcium channel in various regions of the brain and the superficial dorsal horn of the spinal cord. The mechanism by which gabapentin exerts its analgesic action is unknown, but in animal models of analgesia, gabapentin prevents allodynia (pain-related behavior in response to a normally innocuous stimulus) and hyperalgesia (exaggerated response to painful stimuli). In particular, gabapentin prevents pain-related responses in several models of neuropathic pain in rats and mice. Gabapentin also decreases pain-related responses after peripheral inflammation.

Nortriptyline

  • Nortriptyline inhibits the neuronal reuptake of the norepinephrine (NE), as well as serotonin (5-HT). It is relatively more selective inhibitor of NE reuptake. Nortriptyline is thought to promote accumulation of NE and 5-HT in the descending inhibitory pathways from the brain to the spinal cord that modulate pain impulse transmission. NE and 5-HT being the principal neurotransmitters in these pathways, activation of these pathways by nortriptyline results in enhanced negative modulation of pain impulse transmission. This action may account for decreased perception of neuropathic pain.

Pharmacokinetics

Gabapentin

  • Gabapentin bioavailability is not dose proportional; i.e., as dose is increased, bioavailability decreases. Food has only a slight effect on the rate and extent of absorption of gabapentin. Less than 3% of gabapentin circulates bound to plasma protein. The apparent volume of distribution of gabapentin after 150 mg intravenous administration is 58 ± 6 L (Mean ± SD). Gabapentin is eliminated from the systemic circulation by renal excretion as unchanged drug. Gabapentin is not appreciably metabolized in humans. Gabapentin elimination half-life is 5 to 7 hours and is unaltered by dose or following multiple dosing.

Nortriptyline

  • Most tricyclic antidepressants are incompletely absorbed and undergo significant first-pass metabolism. The absolute oral bioavailability of nortriptyline is 32-79%. Nortriptyline is 92% bound to plasma proteins. It has relatively high lipid solubility; volumes of distribution tend to be very large (about 1300L/kg). Nortriptyline has mainly hepatic metabolism and is metabolized to form active 10-hydroxy derivatives. The oral clearance of nortriptyline is 30 L/hr; very small amount of the drug (about 2%) is excreted via urine. The mean terminal half-life of nortriptyline is 21-57 hours. Nortriptyline follows linear pharmacokinetics and therapeutic plasma concentration range is approximately 50-150 ng/ml.

Inidcations

  • GABAPIN NT is indicated for the treatment of pain associated with peripheral neuropathic conditions in adults.

Contraindications

GABAPIN NT is contraindicated in the following conditions:

  • Hypersensitivity to gabapentin or nortriptyline, other tricyclic antidepressants, or to any ingredient in the formulation
  • Pregnancy and lactation
  • Acute recovery period after myocardial infarction
  • Concomitant use with monoamine oxidase inhibitors

Dosage And Administration

  • GABAPIN NT is given orally with or without food. If GABAPIN NT dose is reduced, discontinued or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).
  • In adults with painful neuropathic conditions such as post-herpetic neuralgia, GABAPIN NT 400 therapy should be initiated as a single tablet taken on day 1, one tablet to be taken twice daily day 2, one tablet thrice a day (t.i.d.) on day 3 and thereafter the dose can be titrated up as needed for pain relief by successively adding one tablet to existing t.i.d. regimen to reach the maximum recommended dose of 2400 mg gabapentin or 60 mg nortriptyline per day. Attempt should be made to titrate the dosage to a maintenance level that is well tolerated as well as effective. Periodic reassessment of the patient for his need to take GABAPIN NT should be made.

Use In Special Population

Pediatric Use

  • Use of GABAPIN NT in pediatric patients is not recommended.

Geriatric Use

  • GABAPIN NT should be used cautiously in elderly subjects.
  • Gabapentin is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. The safety and effectiveness of nortriptyline in the geriatric population have not been established fully.
  • Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients

Use in Pregnancy and Lactation

  • Use of GABAPIN NT is not recommended.

Gabapentin

  • Pregnancy Category C.

Nortriptyline

  • Pregnancy Category D.

Dosage in Renal Impairment

  • In adult and elderly patients with renal impairment the recommended dosages of GABAPIN NT are as follows:
Renal Function[Creatinine Clearance](ml/min) GABAPIN NT 400 Tablet Dosage (No. of tablets per day) GABAPIN NT 100 Tablet Dosage (No. of tablets per day)
≥60 1-4 1-6
≥30-59 1-3 1-6
≥15-29 1-2 1-6
15 Not recommended 1-3

Dosage in Hepatic Impairment

  • Dosage adjustment of GABAPIN NT is not needed in mild to moderate hepatic impairment. It is not recommended for use in severe hepatic impairment.

Warnigs And Precautions

Clinical Worsening and Suicide Risk

  • Antiepileptic drugs, including gabapentin and antidepressant drugs, including nortriptyline can increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Families and caregivers of patients being treated with antidepressants or antiepileptics for any indications should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers.

Tumorigenic Potential

  • In standard preclinical in vivo lifetime carcinogenicity studies with gabapentin an unexpectedly high incidence of pancreatic acinar adenocarcinomas was identified in male, but not female rats.

Sudden and Unexplained Death in Patients with Epilepsy

  • In post-marketing study sudden and unexplained death in patients with epilepsy had been reported with use of gabapentin.

Additional Precautions

Gabapentin

  • Patients should be advised that gabapetntin may cause dizziness, somnolence and other symptoms and signs of CNS depression. Accordingly, they should be advised neither to drive a vehicle nor to operate other complex machinery until they have gained sufficient experience on gabapentin to gauge whether or not it affects their mental and/or motor performance adversely.

Nortriptyline

  • Patients with bipolar disorder: It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder.
  • Patients with a history of seizures should be followed closely when nortriptyline is administered, as this drug is known to lower the convulsive threshold.
  • Antiepileptic drugs should not be abruptly discontinued because of the possibility of increasing seizure frequency.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Gabapentin

  • A statistically significant increase in the incidence of pancreatic acinar cell adenomas and carcinomas was found in male rats receiving the high dose of gabapentin. Gabapentin did not demonstrate mutagenic or genotoxic potential in vitro and in vivo assays. No adverse effects on fertility or reproduction were observed in rats.

Nortriptyline

  • Studies are not described.

Drug Interactions

Gabapentin

  • Coadministration with naproxen, hydrocodon, morphine can leads to increased bioavaibility of gabapentin.
  • Cimetidine and probenecid coadministration can alter the renal excretion of gabapentin
  • Antacid like aluminum hydroxide and magnesium hydroxide can reduce the bioavailability of gabapentin.
  • The peak plasma concentration of norethindrone can increase when orally coadministered with gabapentin.
  • Gabapentin is not appreciably metabolized nor does it interfere with the metabolism of commonly coadministered antiepileptic drugs such as phenytoin, carbamazepine, valproic acid and phenobarbitone.

Nortriptyline

  • Close supervision and careful adjustment of the dosage are required when nortriptyline hydrochloride is used with other anticholinergic drugs and sympathomimetic drugs.
  • Concurrent administration of cimetidine and tricyclic antidepressants can produce clinically significant increases in the plasma concentrations of the tricyclic antidepressant.
  • The patient should be informed that the response to alcohol may be exaggerated.
  • Administration of reserpine during therapy with a tricyclic antidepressant has been shown to produce a “stimulating” effect in some depressed patients.
  • A case of significant hypoglycemia has been reported in a type II diabetic patient maintained on chlorpropamide (250 mg/day), after the addition of nortriptyline (125 mg/day).
  • Concomitant use of nortriptyline with drugs that can inhibit cytochrome P450 2D6 such as selective serotonin reuptake inhibitors (SSRIs), viz., fluoxetine, sertraline, and paroxetine may require lower doses than usually prescribed.

Adverse Effects

  • Adverse effects to GABAPIN NT pertain to those associated with the use of its two individual components.

Gabapentin

  • The most commonly reported adverse events associated with the use of gabapentin in adults are dizziness, somnolence, and peripheral edema.

Other important side effects, system-wise, are mentioned below:

  • Body as a Whole: asthenia, malaise, face edema, allergy, generalized edema
  • Cardiovascular System: hypertension, hypotension, palpitation, tachycardia, murmur
  • Endocrine System: hyperthyroid, hypothyroid, goiter, hypoestrogen, ovarian failure, epididymitis, swollen testicle, cushingoid appearance
  • Hematologic and Lymphatic System: purpura; thrombocytopenia
  • Musculoskeletal System: arthralgia, tendinitis, arthritis, joint stiffness, joint swelling
  • Nervous System: vertigo, hyperkinesia, paresthesia, ataxia, tremors; dystonia, decreased or absent reflexes, increased reflexes, anxiety, hostility, syncope, dreaming abnormal, aphasia, hypoesthesia, intracranial hemorrhage, hypotonia, dysesthesia
  • Psychiatric: exacerbation of psychoses, euphoria, agitation, paranoia
  • Respiratory System: pneumonia, epistaxis, dyspnea, apnea
  • Dermatological: alopecia, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea
  • Urogenital System: hematuria, dysuria, urination frequency, cystitis, urinary retention, urinary incontinence, vaginal hemorrhage, amenorrhea, dysmenorrhea, menorrhagia, breast cancer, unable to climax, ejaculation abnormal
  • Special Senses: abnormal vision, hearing loss, earache, tinnitus, unusual taste

Nortriptyline

  • The most commonly reported side effects with nortriptyline are hypotension, sedation, dry mouth, seizures, weight gain, gynecomastia in the male, and breast enlargement and galactorrhea in the female.

Other important side effects, system-wise, are mentioned below:

  • Cardiovascular System: hypertension, hypotension, palpitation, tachycardia, murmur
  • Nervous System: numbness, tingling, incoordination, ataxia, tremors, peripheral neuropathy, extrapyramidal symptoms, alteration in EEG patterns, tinnitus.
  • Psychiatric: confusional states (especially in the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia, panic, nightmares; hypomania; exacerbation of psychosis, euphoria
  • Allergic: skin rash, petechiae, urticaria, itching, photosensitization, edema (general or of face and tongue), drug fever, cross-sensitivity with other tricyclic drugs
  • Anticholinergic: dry mouth, blurred vision, disturbance of accommodation, mydriasis, constipation, paralytic ileus, urinary retention, delayed micturition, dilation of the urinary tract
  • Digestive System: nausea and vomiting, anorexia, diarrhea, abdominal cramps, black tongue
  • Endocrine System: gynecomastia in the male, breast enlargement and galactorrhea in the female
  • Hematological and lymphatic system: bone marrow depression, agranulocytosis, eosinophilia
  • Other: jaundice (simulating obstructive), altered liver function, weight gain or loss
  • Withdrawal Symptoms: though these are not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache, and malaise.

Overdose

Symptoms

Gabapentin

  • Acute oral overdoses of gabapentin up to 49 grams have been reported. In these cases, double vision, slurred speech, drowsiness, lethargy and diarrhea were observed

Nortriptyline

  • Critical manifestations of overdose include: cardiac dysrhythmias, severe hypotension, shock, congestive heart failure, pulmonary edema, convulsions, and CNS depression, including coma. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of tricyclic antidepressant toxicity. Other signs of overdose may include: confusion, restlessness, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia, or any of the acute symptoms listed under ADVERSE EFFECTS.

Management

Gabapentin

  • There is no specific antidote. Patients recovered with supportive care. Gabapentin can be removed by hemodialysis. Although hemodialysis has not been performed in the few overdose cases reported, it may be indicated by the patient's clinical state or in patients with significant renal impairment.

Nortriptyline

  • There is no specific antidote. There have been reports of patients recovering from nortriptyline overdoses of up to 525 mg with no associated fatalities.

General

  • The main treatment of toxicity is symptomatic and includes specifically the basic management of airway and respiration. Gastric lavage with activated charcoal should be done. Vital sign monitoring along with general symptomatic and supportive care is required.

Supportive Therapy

  • The electrocardiogram, pulse, blood pressure, neurobehavioral status of the patient and his intake and output balance must be monitored. Intravenous sodium bicarbonate should be used to maintain the serum pH in the range of 7.45 to 7.55. Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium or phenytoin. Hemoperfusion may be beneficial in acute refractory cardiovascular instability in patients with acute toxicity. In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration. Seizures should be controlled with benzodiazepines. Psychiatric referral may be appropriate for nortriptyline overdosage after emergency management

Presentation

  • GABAPIN NT 400
  • GABAPIN NT 100.

Storage

  • Store in a cool and dry place at below 30̊C. Protect from light and moisture.
  • Keep all medicines away from the reach of children.

Find us at:

MARKETED BY

INTAS PHARMACEUTICALS LTD.
Corporate House, Near Sola Bridge,
S. G. Highway, Thaltej,
Ahmedabad - 380054. Gujarat. India.
Email: aquila@intaspharma.com



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