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• Progaba indications
• Uses of Progaba in details
• Progaba description
• Progaba dosage
• Progaba interactions
• Progaba side effects
• Progaba contraindications

What is Progaba?

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

Progaba is also used in adults to manage a condition called postherpetic neuralgia, which is pain that occurs after shingles.

Progaba 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. Progaba is an anticonvulsant.

Progaba 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, Progaba is used in certain patients with the following medical condition:

• Diabetic peripheral neuropathy.

Progaba indications

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.

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.

Oral

Restless leg syndrome

Adult: As Progaba enacarbil: Modified-release preparation: Moderate to severe: 600 mg once daily at approx 5 pm.

Renal impairment: As Progaba enacarbil: Modified-release preparation:

Haemodialysis: Not recommended.

Oral

Postherpetic neuralgia

Adult: As Progaba enacarbil: Modified-release preparation: Initially, 600 mg in the morning for 3 days, then increased to 600 mg bid.

Renal impairment: As Progaba enacarbil: Modified-release preparation:

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

How should I use Progaba?

Use Progaba capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Progaba capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Progaba capsules refilled.
• Take Progaba capsules by mouth with or without food.
• Swallow Progaba 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 Progaba capsules.
• Do not suddenly stop taking Progaba capsules. Patients taking Progaba capsules to prevent seizures may have an increased risk of seizures if the medicine is suddenly stopped. If you need to stop Progaba capsules or add a new medicine, your doctor will gradually lower your dose.
• If you miss a dose of Progaba 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 Progaba capsules.

Uses of Progaba in details

Progaba 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. Progaba 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.

Progaba 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 Progaba

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking Progaba 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 Progaba 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 Progaba at least 2 hours after taking the antacid.

Different forms of Progaba (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.

Progaba description

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

Progaba dosage

Progaba Dosage

Generic name: Progaba 300mg

Dosage form: tablet, film coated

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Postherpetic Neuralgia

Do not use Progaba interchangeably with other Progaba products.

Titrate Progaba to an 1800 mg dose taken orally once daily with the evening meal. Progaba tablets should be swallowed whole. Do not split, crush, or chew the tablets.

If Progaba 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, Progaba 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 Progaba should be adjusted in patients with reduced renal function, according to Table 2. Patients with reduced renal function must initiate Progaba at a daily dose of 300 mg. Progaba 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.

More about Progaba (Progaba)

• Side Effects
• During Pregnancy or Breastfeeding
• Dosage Information
• Drug Images
• Drug Interactions
• Support Group
• En Espanol
• 5 Reviews - Add your own review/rating

Consumer resources

• Progaba
• Progaba (Advanced Reading)

• Other brands: Progaba, Progaba

Professional resources

• Progaba (FDA)
• Progaba (AHFS Monograph)

Related treatment guides

• Postherpetic Neuralgia

Progaba interactions

See also:
What other drugs will affect Progaba?

There are spontaneous and literature case reports of respiratory depression and/or sedation associated with Progaba and opioid use. In some of these reports, the authors considered this a particular concern with the combination of Progaba and opioids, especially in elderly patients.

Morphine: In a study involving healthy volunteers (N=12) when a 60 mg controlled-release morphine capsule was administered 2 hours prior to a 600 mg Progaba capsule, mean Progaba AUC increased by 44% compared to Progaba administered without morphine. This was associated with an increased pain threshold (cold pressor test). The clinical significance of such changes has not been defined. Morphine pharmacokinetic parameter values were not affected by administration of Progaba 2 hours after morphine. The observed opioid-mediated side effects associated with morphine plus Progaba did not differ significantly from morphine plus placebo. The magnitude of interaction at other doses is not known.

No interaction between Progaba and phenobarbital, phenytoin, valproic acid or carbamazepine has been observed. Progaba steady-state pharmacokinetics are similar for healthy subjects and patients with epilepsy receiving these antiepileptic agents.

Co-administration of Progaba with oral contraceptives containing norethindrone and/or ethinyl estradiol does not influence the steady-state pharmacokinetics of either component.

Co-administration of Progaba with antacids containing aluminum and magnesium reduces Progaba bioavailability by about 20%. It is recommended that Progaba be taken about 2 hours following antacid administration.

Renal excretion of Progaba is unaltered by probenecid.

A slight decrease in renal excretion of Progaba observed when it is co-administered with cimetidine is not expected to be of clinical importance.

Laboratory Tests: False-positive readings were reported in the Ames N-Multistix SG dipstick test when Progaba was added to other anticonvulsant drugs. To determine urinary protein, the more specific sulfosalicylic acid precipitation procedure is recommended.

Progaba side effects

See also:
What are the possible side effects of Progaba?

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

A total of 359 patients with neuropathic pain associated with postherpetic neuralgia have received Progaba at doses up to 1800 mg daily during placebo-controlled clinical studies. In clinical trials in patients with postherpetic neuralgia, 9.7% of the 359 patients treated with

Progaba and 6.9% of 364 patients treated with placebo discontinued prematurely due to adverse reactions. In the Progaba treatment group, the most common reason for discontinuation due to adverse reactions was dizziness. Of Progaba-treated patients who experienced adverse reactions in clinical studies, the majority of those adverse reactions were either “mild” or “moderate”.

Table 4 lists all adverse reactions, regardless of causality, occurring in at least 1% of patients with neuropathic pain associated with postherpetic neuralgia in the Progaba group for which the incidence was greater than in the placebo group.

Table 4: Treatment-Emergent Adverse Reaction Incidence in Controlled Trials in Neuropathic Pain Associated with Postherpetic Neuralgia (Events in at Least 1% of all Progaba-Treated Patients and More Frequent Than in the Placebo Group)

In addition to the adverse reactions reported in Table 4 above, the following adverse reactions with an uncertain relationship to Progaba were reported during the clinical development for the treatment of postherpetic neuralgia. Events in more than 1% of patients but equally or more frequently in the Progaba-treated patients than in the placebo group included blood pressure increase, confusional state, gastroenteritis viral, herpes zoster, hypertension, joint swelling, memory impairment, nausea, pneumonia, pyrexia, rash, seasonal allergy, and upper respiratory infection.

Postmarketing And Other Experience With Other Formulations Of Progaba

In addition to the adverse experiences reported during clinical testing of Progaba, the following adverse experiences have been reported in patients receiving other formulations of marketed Progaba. These adverse experiences have not been listed above and data are insufficient to support an estimate of their incidence or to establish causation. The listing is alphabetized: angioedema, blood glucose fluctuation, breast enlargement, elevated creatine kinase, elevated liver function tests, erythema multiforme, fever, hyponatremia, jaundice, movement disorder, Stevens-Johnson syndrome.

Adverse events following the abrupt discontinuation of Progaba immediate release have also been reported. The most frequently reported events were anxiety, insomnia, nausea, pain and sweating.

Progaba contraindications

See also:
What is the most important information I should know about Progaba?

You should not use this medication if you are allergic to Progaba.

Before taking Progaba, tell your doctor if you have kidney, liver, or heart disease.

You may have thoughts about suicide while taking Progaba. 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 Progaba for seizures without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using Progaba 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 Progaba.

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

Active ingredient matches for Progaba:

Gabapentin in India.

Lidocaine

References

1. DailyMed. "LIDOCAINE; TETRACAINE: 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. DailyMed. "GABAPENTIN: 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).
3. PubChem. "lidocaine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology