Andogablin Uses

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What is Andogablin?

Andogablin (Andogablin) is an anti-epileptic drug, also called an anticonvulsant. Andogablin works by slowing down nerve impulses in the brain and affects chemicals that send pain signals across the nervous system.

Andogablin is a prescription medicine used to treat pain caused by damaged nerves in people with diabetes (diabetic neuropathy). Andogablin is also used to treat pain caused by damaged nerves (neuropathic pain) that follows healing of shingles (herpes zoster). This condition is called post-herpetic neuralgia.

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It is not known if Andogablin is effective when used for the treatment of fibromyalgia, or when taken with other seizure medicines for adults with partial onset seizures.

Andogablin is supplied as extended-release tablets in the following strengths: 82.5 mg, 165 mg, and 330 mg.

Andogablin 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.
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Neuropathic Pain: Andogablin is indicated for the treatment of neuropathic pain in adults, including neuropathic pain associated with spinal cord injury.

Epilepsy: Andogablin is indicated as adjunctive therapy in adults with partial seizures, with or without secondary generalization.

Generalized Anxiety Disorder: Andogablin is indicated for the treatment of Generalized Anxiety Disorder (GAD) in adults.

Fibromyalgia: Andogablin is indicated for the management of fibromyalgia.

How should I use Andogablin?

Use Andogablin 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 Andogablin solution.

Uses of Andogablin in details

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.
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Use: Labeled Indications

Fibromyalgia (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 Uses

Cough, chronic refractory

Data from a limited number of patients in a controlled trial suggest that Andogablin 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, Andogablin 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.

Andogablin description

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Each capsule contains the following inactive ingredients: Mannitol, maize starch and talc.

Andogablin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23.

Andogablin 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.

Andogablin dosage

The dose range is 150 to 600 mg per day given in either two or three divided doses.

Epilepsy: Andogablin 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.

Andogablin 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 Andogablin: In accordance with current clinical practice, if Andogablin 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: Andogablin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug. As Andogablin 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.

Andogablin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours). For patients receiving haemodialysis, the Andogablin 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 Andogablin 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 Andogablin due to a decreased renal function.

Administration: Andogablin Sandoz may be taken with or without food.

Andogablin Sandoz is for oral use only.

Andogablin interactions

See also:
What other drugs will affect Andogablin?

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Since Andogablin 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 Andogablin is unlikely to be involved in significant pharmacokinetic drug interactions. Specifically, there are no pharmacokinetic interactions between Andogablin and the following antiepileptic drugs: carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital, and topiramate. Important pharmacokinetic interactions would also not be expected to occur between Andogablin and commonly used antiepileptic drugs.

Pharmacodynamics

Multiple oral doses of Andogablin 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 Andogablin was co-administered with these drugs. No clinically important effects on respiration were seen.

Drug Abuse And Dependence

Controlled Substance

Andogablin is a Schedule V controlled substance.

Andogablin 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 Andogablin misuse or abuse (e.g., development of tolerance, dose escalation, drug-seeking behavior).

Abuse

In a study of recreational users (N=15) of sedative/hypnotic drugs, including alcohol, Andogablin (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 Andogablin-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%.

Dependence

In clinical studies, following abrupt or rapid discontinuation of Andogablin, 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.

Andogablin side effects

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What are the possible side effects of Andogablin?

The Andogablin clinical programme involved over 8900 patients who were exposed to Andogablin, 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 Andogablin and 5% for patients receiving placebo. The most common adverse reactions resulting in discontinuation from Andogablin 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 Andogablin 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 Andogablin, data suggest that the incidence and severity of withdrawal symptoms may be dose-related.

Andogablin contraindications

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What is the most important information I should know about Andogablin?

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 Andogablin to prevent seizures, keep taking the medication even if you feel fine.

Do not stop using Andogablin 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 Andogablin.

Do not change your dose of Andogablin 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 Andogablin. Any medical care provider who treats you should know that you take seizure medication.



Active ingredient matches for Andogablin:

Pregabalin in Egypt.


List of Andogablin substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Apo-pregabalin capsule 25 mg (Apotex Inc (Canada))
Apo-pregabalin capsule 225 mg (Apotex Inc (Canada))
Apo-pregabalin capsule 50 mg (Apotex Inc (Canada))
Apo-pregabalin capsule 300 mg (Apotex Inc (Canada))
Apo-pregabalin capsule 75 mg (Apotex Inc (Canada))
Apo-pregabalin capsule 150 mg (Apotex Inc (Canada))
Asmeth-P Pregabalin 75 mg, methylcobalamin 500 mcg. TAB / 100 (Astrum)
ASMETH-P tab 10's (Astrum)
Auro-pregabalin capsule 100 mg (Auro Pharma Inc (Canada))
Auro-pregabalin capsule 25 mg (Auro Pharma Inc (Canada))
Auro-pregabalin capsule 200 mg (Auro Pharma Inc (Canada))
Auro-pregabalin capsule 50 mg (Auro Pharma Inc (Canada))
Auro-pregabalin capsule 225 mg (Auro Pharma Inc (Canada))
Auro-pregabalin capsule 75 mg (Auro Pharma Inc (Canada))
Auro-pregabalin capsule 300 mg (Auro Pharma Inc (Canada))
Auro-pregabalin capsule 150 mg (Auro Pharma Inc (Canada))
AVERTZ 150 MG TABLET 1 strip / 10 tablets each (Dr. Reddy's)$ 2.06
AVERTZ 75 MG TABLET 1 strip / 10 tablets each (Dr. Reddy's)$ 1.43
AVERTZ tab 75 mg x 10's (Dr. Reddy's)$ 1.27
AVERTZ tab 150 mg x 10's (Dr. Reddy's)$ 2.06

References

  1. DailyMed. "PREGABALIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "Pregabalin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "Pregabalin". http://www.drugbank.ca/drugs/DB00230 (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Andogablin are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Andogablin. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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