Andogablin Dosage

• Dosage of Andogablin in details
• Andogablin interactions
• Andogablin reviews

Dosage of Andogablin in details

Important Dosage and Administration Instructions

Andogablin extended-release tablets should be administered once daily after an evening meal.

Andogablin extended-release tablets should be swallowed whole and should not be split, crushed, or chewed.

When discontinuing Andogablin extended-release tablets, taper gradually over a minimum of 1 week.

Instruct patients that if they miss taking their dose of Andogablin extended-release tablets after an evening meal, then they should take their usual dose of Andogablin extended-release tablets prior to bedtime following a snack. If they miss taking the dose of Andogablin extended-release tablets prior to bedtime, then they should take their usual dose of Andogablin extended-release tablets following a morning meal. If they miss taking the dose of Andogablin extended-release tablets following the morning meal, then they should take their usual dose of Andogablin extended-release tablets at the usual time that evening following an evening meal.

Neuropathic Pain Associated with Diabetic Peripheral Neuropathy

Begin dosing at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. The maximum recommended dose of Andogablin extended-release tablets are 330 mg once daily.

Although Andogablin was studied at 600 mg/day, there was no evidence that this dose conferred additional significant benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions with Andogablin, treatment with doses above 330 mg/day is not recommended for Andogablin extended-release tablets.

Postherpetic Neuralgia

Begin dosing at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability.

Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 330 mg once daily and who are able to tolerate Andogablin extended-release tablets, may be treated with up to 660 mg once daily. In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, dosing above 330 mg/day should be reserved only for those patients who have on-going pain and are tolerating 330 mg daily. The maximum recommended dose of Andogablin extended-release tablets are 660 mg once daily.

Conversion from Andogablin Capsules or

Oral Solution to Andogablin Extended-Release Tablets

When switching from Andogablin Capsules or

Oral Solution to Andogablin Extended-Release Tablets on the day of the switch, instruct patients to take their morning dose of Andogablin Capsules or

Oral Solution as prescribed and initiate Andogablin extended-release tablets therapy after an evening meal.

Table 1. Conversion from Andogablin Capsules or

Oral Solution to Andogablin Extended-Release Tablets

Andogablin Capsules or Oral Solution Total Daily Dose (dosed 2 or 3 times daily)	Andogablin extended-release tablets Dose (dosed once a day)
75 mg/daily	82.5 mg/day
150 mg/daily	165 mg/day
225 mg/daily	247.5 mg/daya
300 mg/daily	330 mg/day
450 mg/daily	495 mg/dayb
600 mg/daily	660 mg/dayc

1.

247.5 mg = 3 times 82.5 mg tablets taken once a day.

2.

495 mg = 3 times 165 mg tablets taken once a day.

3.

660 mg = 2 times 330 mg tablets taken once a day.

Patients with Renal Impairment

Use of Andogablin extended-release tablets are not recommended for patients with creatinine clearance (CLcr) less than 30 mL/min or who are undergoing hemodialysis. Those patients should receive Andogablin Capsules or

Oral Solution.

In view of dose-dependent adverse reactions and because Andogablin is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function. Base the dose adjustment in patients with renal impairment on CLcr, as indicated in Table 2. To use the dosing tables, an estimate of the patient's CLcr

in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the

Cockcroft and Gault equation:

CLCr=	[140-age (years)] x weight (kg)	(x 0.85 for female patients)
	72 x serum creatinine (mg/dL)

Next, refer to the Dosage and Administration section to determine the recommended total daily dose based on indication, for a patient with normal renal function (CLcr greater than or equal to 60 mL/min). Then refer to Table 2 to determine the corresponding renal adjusted dose.

(For example: A patient initiating Andogablin extended-release tablets therapy for postherpetic neuralgia with normal renal function [CLcr greater than or equal to 60 mL/min], receives a single daily dose of 165 mg/day Andogablin. Therefore, a renal impaired patient with a CLcr of 50 mL/min would receive a single daily dose of 82.5 mg.)

Table 2. Andogablin extended-release tablets Dosage Adjustment Based on Renal Function

Creatinine Clearance (CLcr) (mL/min)	Total Andogablin extended-release tablets Daily Dose (mg/day)				Dose Regimen
greater than or equal to 60	165	330	495a	660b	Once a day
30 to 60	82.5	165	247.5c	330	Once a day
less than 30/hemodialysis	Dose with Andogablin Capsules or Oral Solution

1.

495 mg = 3 times 165 mg tablets taken once a day.

2.

660 mg = 2 times 330 mg tablets taken once a day.

3.

247.5 mg = 3 times 82.5 mg tablets taken once a day.

What other drugs will affect Andogablin?

Using Andogablin with other drugs that slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, cold or allergy medicine, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• oral diabetes medicine - pioglitazone, rosiglitazone; or

• an ACE inhibitor - benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril.

This list is not complete. Other drugs may interact with Andogablin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Andogablin drug interactions (more detail)

Andogablin interactions

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.

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. FDA/SPL Indexing Data. "55JG375S6M: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
3. MeSH. "Anticonvulsants". https://www.ncbi.nlm.nih.gov/mesh/68... (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