See also:
What is the most important information I should know about Nortriptyline (Gabawin NT)?
The use of MAOIs intended to treat psychiatric disorders with Nortriptyline (Gabawin NT) hydrochloride or within 14 days of stopping treatment with Nortriptyline (Gabawin NT) hydrochloride is contraindicated because of an increased risk of serotonin syndrome. The use of Nortriptyline (Gabawin NT) hydrochloride within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (seeWARNINGSandDOSAGE AND ADMINISTRATION).
Starting Nortriptyline (Gabawin NT) hydrochloride in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (seeWARNINGS and DOSAGE AND ADMINISTRATION).
Hypersensitivity to Tricyclic Antidepressants
Cross-sensitivity between Nortriptyline (Gabawin NT) hydrochloride and other dibenzazepines is a possibility.
Myocardial Infarction
Nortriptyline (Gabawin NT) hydrochloride is contraindicated during the acute recovery period after myocardial infarction.
See also:
What is the most important information I should know about Pregabalin (Gabawin NT)?
You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.
Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, insomnia, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
If you are taking Pregabalin (Gabawin NT) to prevent seizures, keep taking the medication even if you feel fine.
Do not stop using Pregabalin (Gabawin NT) without first talking to your doctor, even if you feel fine. You may have increased seizures or withdrawal symptoms such as headache, sleep problems, nausea, and diarrhea. Ask your doctor how to avoid withdrawal symptoms when you stop using Pregabalin (Gabawin NT).
Do not change your dose of Pregabalin (Gabawin NT) without your doctor's advice. Tell your doctor if the medication does not seem to work as well in treating your condition.
Wear a medical alert tag or carry an ID card stating that you take Pregabalin (Gabawin NT). Any medical care provider who treats you should know that you take seizure medication.
See also:
What are the possible side effects of Nortriptyline (Gabawin NT)?
Applies to Nortriptyline (Gabawin NT): oral capsule, oral solution, oral tablet
As well as its needed effects, Nortriptyline (Gabawin NT) (the active ingredient contained in Nortriptyline (Gabawin NT)) may cause unwanted side effects that require medical attention.
Major Side EffectsIf any of the following side effects occur while taking Nortriptyline (Gabawin NT), check with your doctor immediately:
Incidence not known:
Some Nortriptyline (Gabawin NT) side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:
Incidence not known:
See also:
What are the possible side effects of Pregabalin (Gabawin NT)?
The Pregabalin (Gabawin NT) clinical programme involved over 8900 patients who were exposed to Pregabalin (Gabawin NT), of whom over 5600 were in double-blind placebo controlled trials. The most commonly reported adverse reactions were dizziness and somnolence. Adverse reactions were usually mild to moderate in intensity. In all controlled studies, the discontinuation rate due to adverse reactions was 12% for patients receiving Pregabalin (Gabawin NT) and 5% for patients receiving placebo. The most common adverse reactions resulting in discontinuation from Pregabalin (Gabawin NT) treatment groups were dizziness and somnolence.
In Table 2, all adverse reactions which occurred at an incidence greater than placebo and in more than one patient, are listed by class and frequency: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<l/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
The adverse reactions listed may also be associated with the underlying disease and/or concomitant medicinal products.
In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions in general, CNS adverse reactions and especially somnolence was increased.
Additional reactions reported from post-marketing experience are included as Frequency not known in italics in the table below.
After discontinuation of short-term and long-term treatment with Pregabalin (Gabawin NT) withdrawal symptoms have been observed in some patients. The following reactions have been mentioned: Insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, convulsions, nervousness, depression, pain, hyperhidrosis and dizziness, suggestive of physical dependence. The patient should be informed about this at the start of the treatment.
Concerning discontinuation of long-term treatment of Pregabalin (Gabawin NT), data suggest that the incidence and severity of withdrawal symptoms may be dose-related.
Nortriptyline (Gabawin NT)™ (Nortriptyline (Gabawin NT) HCl) is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.
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.Neuropathic Pain: Pregabalin (Gabawin NT) is indicated for the treatment of neuropathic pain in adults, including neuropathic pain associated with spinal cord injury.
Epilepsy: Pregabalin (Gabawin NT) is indicated as adjunctive therapy in adults with partial seizures, with or without secondary generalization.
Generalized Anxiety Disorder: Pregabalin (Gabawin NT) is indicated for the treatment of Generalized Anxiety Disorder (GAD) in adults.
Fibromyalgia: Pregabalin (Gabawin NT) is indicated for the management of fibromyalgia.
Nortriptyline (Gabawin NT) is a tricyclic antidepressant. Nortriptyline (Gabawin NT) affects chemicals in the brain that may become unbalanced.
Nortriptyline (Gabawin NT) is used to treat symptoms of depression.
Nortriptyline (Gabawin NT) may also be used for purposes not listed in this medication guide.
Pregabalin (Gabawin NT) is used with other medicines to help control partial seizures (convulsions) in the treatment of epilepsy. Pregabalin (Gabawin NT) will not cure epilepsy and will only work to control seizures for as long as you continue to take it.
Pregabalin (Gabawin NT) is also used for postherpetic neuralgia (pain that occurs after shingles) and pain caused by nerve damage from diabetes or a spinal cord injury. It is used to treat a condition called fibromyalgia (muscle pain and stiffness).
Pregabalin (Gabawin NT) works in the central nervous system (CNS) to control seizures and pain. It is an anticonvulsant and neuropathic pain agent.
Pregabalin (Gabawin NT) is available only with your doctor's prescription.
Nortriptyline (Gabawin NT) hydrochloride, the N-demethylated active metabolite of amitriptyline, 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, Nortriptyline (Gabawin NT) does not affect mood or arousal, but may cause sedation. In depressed individuals, Nortriptyline (Gabawin NT) exerts a positive effect on mood. TCAs are potent inhibitors of serotonin and norepinephrine reuptake. Secondary amine TCAs, such as Nortriptyline (Gabawin NT), are more potent inhibitors of norepinephrine reuptake than tertiary amine TCAs, such as amitriptyline. 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. Nortriptyline (Gabawin NT) exerts less anticholinergic and sedative side effects compared to the tertiary amine TCAs, amitriptyline and clomipramine. Nortriptyline (Gabawin NT) 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).
Each capsule contains the following inactive ingredients: Mannitol, maize starch and talc.
Pregabalin (Gabawin NT) is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23.
Pregabalin (Gabawin NT) is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05 M phosphate buffer) at pH 7.4 is -1.35.
Use Nortriptyline (Gabawin NT) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Nortriptyline (Gabawin NT).
Use Pregabalin (Gabawin NT) solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Pregabalin (Gabawin NT) solution.
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, 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) 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 help quit smoking.
How to use Nortriptyline (Gabawin NT)Read the Medication Guide provided by your pharmacist before you start taking Nortriptyline (Gabawin NT) 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 are using the liquid form, measure the dose carefully using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects (such as 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 IndicationsFibromyalgia (immediate release only): Management of fibromyalgia
Neuropathic pain associated with diabetic peripheral neuropathy (immediate release and extended release): Management of neuropathic pain associated with diabetic peripheral neuropathy
Neuropathic pain associated with spinal cord injury (immediate release only): Management of neuropathic pain associated with spinal cord injury
Postherpetic neuralgia (immediate release and extended release): Management of postherpetic neuralgia
Seizures, focal (partial) onset (immediate release only): Adjunctive therapy in patients ≥1 month of age with focal onset (partial-onset) seizures
Off Label UsesCough, chronic refractory
Data from a limited number of patients in a controlled trial suggest that Pregabalin (Gabawin NT) in combination with speech pathology therapy may be beneficial for the treatment of refractory chronic cough.
Based on the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE) position statement on menopause, the Endocrine Society guideline on the treatment of symptoms of menopause, and the North American Menopause Society (NAMS) position statement on nonhormonal management of menopause-associated vasomotor symptoms, Pregabalin (Gabawin NT) is an effective and recommended alternative for the management of vasomotor symptoms associated with menopause in patients with contraindications to hormonal therapy or who prefer not to use hormonal therapy.
Nortriptyline (Gabawin NT) is not recommended for children.
Nortriptyline (Gabawin NT) is administered orally in the form oforal solution.. Lower than usual dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients than for hospitalized patients who will be under close supervision. The physician should initiate dosage at a low level and increase it gradually, noting carefully the clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a longer period of time at the lowest dose that will maintain remission.
If a patient develops minor side effects, the dosage should be reduced. The drug should be discontinued promptly if adverse effects of a serious nature or allergic manifestations occur.
Usual Adult Dose25 mg three or four times daily; dosage should begin at a low level and be increased as required. As an alternate regimen, the total daily dosage may be given once a day. When doses above 100 mg daily are administered, plasma levels of Nortriptyline (Gabawin NT) should be monitored and maintained in the optimum range of 50 to 150 ng/mL. Doses above 150 mg/day are not recommended.
Elderly and Adolescent Patients30 to 50 mg/day, in divided doses, or the total daily dosage may be given once a day.
Switching A Patient To Or From A Monoamine Oxidase Inhibitor (MAOI) Intended To Treat Psychiatric DisordersAt least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Nortriptyline (Gabawin NT). Conversely, at least 14 days should be allowed after stopping Nortriptyline (Gabawin NT) before starting an MAOI intended to treat psychiatric disorders.
Use Of Nortriptyline (Gabawin NT) With Other MAOIs, Such As Linezolid Or Methylene BlueDo not start Nortriptyline (Gabawin NT) in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered.
In some cases, a patient already receiving Nortriptyline (Gabawin NT) therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Nortriptyline (Gabawin NT) should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for two weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Nortriptyline (Gabawin NT) may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue.
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with Nortriptyline (Gabawin NT) is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use.
How suppliedNortriptyline (Gabawin NT)™ (Nortriptyline (Gabawin NT) HCl)Oral Solution USPNortriptyline (Gabawin NT)™ (Nortriptyline (Gabawin NT) HCl) oral solution USP, equivalent to 10 mg base per 5 mL, is supplied in 16-fluid-ounce bottles (NDC 0406-9918-16). Alcohol content 4%.
Store And DispenseStore at 20° to 25°C (68° to 77°F).
Dispense in tight, light-resistant container.
Manufactured by: Novartis Consumer Health, Inc. Lincoln, Nebraska 68517. Manufactured for: Mallinckrodt Inc. Hazelwood, MO 63042 USA. Revised: May 2014
The dose range is 150 to 600 mg per day given in either two or three divided doses.
Epilepsy: Pregabalin (Gabawin NT) treatment can be started with a dose of 150 mg per day given as two or three divided doses. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. The maximum dose of 600 mg per day may be achieved after an additional week.
Generalised Anxiety Disorder: The dose range is 150 to 600 mg per day given as two or three divided doses. The need for treatment should be reassessed regularly.
Pregabalin (Gabawin NT) treatment can be started with a dose of 150 mg per day. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. Following an additional week, the dose may be increased to 450 mg per day. The maximum dose of 600 mg per day may be achieved after an additional week.
Discontinuation of Pregabalin (Gabawin NT): In accordance with current clinical practice, if Pregabalin (Gabawin NT) has to be discontinued, it is recommended this should be done gradually over a minimum of 1 week independent of the indication.
Patients with Renal Impairment: Pregabalin (Gabawin NT) is eliminated from the systemic circulation primarily by renal excretion as unchanged drug. As Pregabalin (Gabawin NT) clearance is directly proportional to creatinine clearance, dose reduction in patients with compromised renal function must be individualised according to creatinine clearance (CrCl), as indicated in Table 1 determined using the following formula.
Pregabalin (Gabawin NT) is removed effectively from plasma by haemodialysis (50% of drug in 4 hours). For patients receiving haemodialysis, the Pregabalin (Gabawin NT) daily dose should be adjusted based on renal function. In addition to the daily dose, a supplementary dose should be given immediately following every 4-hour haemodialysis treatment.
Patients with Hepatic Impairment: No dose adjustment is required for patients with hepatic impairment.
Children: The safety and efficacy of Pregabalin (Gabawin NT) Sandoz in children below the age of 12 years and in adolescents (12-17 years of age) have not been established. No data are available.
Elderly (over 65 years of age): Elderly patients may require a dose reduction of Pregabalin (Gabawin NT) due to a decreased renal function.
Administration: Pregabalin (Gabawin NT) Sandoz may be taken with or without food.
Pregabalin (Gabawin NT) Sandoz is for oral use only.
See also:
What other drugs will affect Nortriptyline (Gabawin NT)?
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, "blood thinners" (such as warfarin), disulfiram, thyroid supplements, 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.
The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.
Other medications can affect the removal of Nortriptyline (Gabawin NT) from your body, thereby affecting how Nortriptyline (Gabawin NT) works. These drugs include cimetidine, terbinafine, drugs to treat irregular heart rate (such as quinidine/propafenone/flecainide). This is not a complete list.
Many drugs besides Nortriptyline (Gabawin NT) 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 Nortriptyline (Gabawin NT), 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.
Nortriptyline (Gabawin NT) is very similar to amitriptyline. Do not use medications containing amitriptyline while using Nortriptyline (Gabawin NT).
See also:
What other drugs will affect Pregabalin (Gabawin NT)?
Since Pregabalin (Gabawin NT) is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (less than 2% of a dose recovered in urine as metabolites), and does not bind to plasma proteins, its pharmacokinetics are unlikely to be affected by other agents through metabolic interactions or protein binding displacement. In vitro and in vivo studies showed that Pregabalin (Gabawin NT) is unlikely to be involved in significant pharmacokinetic drug interactions. Specifically, there are no pharmacokinetic interactions between Pregabalin (Gabawin NT) and the following antiepileptic drugs: carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital, and topiramate. Important pharmacokinetic interactions would also not be expected to occur between Pregabalin (Gabawin NT) and commonly used antiepileptic drugs.
PharmacodynamicsMultiple oral doses of Pregabalin (Gabawin NT) were co-administered with oxycodone, lorazepam, or ethanol. Although no pharmacokinetic interactions were seen, additive effects on cognitive and gross motor functioning were seen when Pregabalin (Gabawin NT) was co-administered with these drugs. No clinically important effects on respiration were seen.
Drug Abuse And DependenceControlled SubstancePregabalin (Gabawin NT) is a Schedule V controlled substance.
Pregabalin (Gabawin NT) is not known to be active at receptor sites associated with drugs of abuse. As with any CNS active drug, carefully evaluate patients for history of drug abuse and observe them for signs of Pregabalin (Gabawin NT) misuse or abuse (e.g., development of tolerance, dose escalation, drug-seeking behavior).
AbuseIn a study of recreational users (N=15) of sedative/hypnotic drugs, including alcohol, Pregabalin (Gabawin NT) (450 mg, single dose) received subjective ratings of “good drug effect,” “high” and “liking” to a degree that was similar to diazepam (30 mg, single dose). In controlled clinical studies in over 5500 patients, 4 % of Pregabalin (Gabawin NT)-treated patients and 1 % of placebo-treated patients overall reported euphoria as an adverse reaction, though in some patient populations studied, this reporting rate was higher and ranged from 1 to 12%.
DependenceIn clinical studies, following abrupt or rapid discontinuation of Pregabalin (Gabawin NT), some patients reported symptoms including insomnia, nausea, headache or diarrhea, consistent with physical dependence. In the postmarketing experience, in addition to these reported symptoms there have also been reported cases of anxiety and hyperhidrosis.
