Phl-Gabapentin Uses

How do you administer this medicine?
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What is Phl-Gabapentin?

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

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

Phl-Gabapentin 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. Phl-Gabapentin is an anticonvulsant.

Phl-Gabapentin 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, Phl-Gabapentin is used in certain patients with the following medical condition:

Phl-Gabapentin indications

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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.

CrCl (ml/min)Dosage Recommendation
<15300 mg on alternate days to 300 mg daily.
15-29300 mg on alternate days to 600 mg daily.
30-49300-900 mg daily.
50-79600-1,800 mg daily.

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.

CrCl (ml/min)Dosage Recommendation
<15300 mg on alternate days to 300 mg daily.
15-29300 mg on alternate days to 600 mg daily.
30-49300-900 mg daily.
50-79600-1,800 mg daily.

Oral

Restless leg syndrome

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

Renal impairment: As Phl-Gabapentin enacarbil: Modified-release preparation:

Haemodialysis: Not recommended.

CrCl (ml/min)Dosage Recommendation
<15300 mg on alternate days.
15-29300 mg daily.
30-59Initially, 300 mg daily, increased to 600 mg daily, if needed.

Oral

Postherpetic neuralgia

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

Renal impairment: As Phl-Gabapentin enacarbil: Modified-release preparation:

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

CrCl (ml/min)Dosage Recommendation
<15300 mg in the morning on alternate days, may increase to 300 mg daily in the morning.
15-29300 mg in the morning on days 1 and 3 followed by 300 mg daily in the morning, may increase to 300 mg bid.
30-59300 mg in the morning for the 1st 3 days followed by 300 mg bid, may increase to 600 mg bid.

How should I use Phl-Gabapentin?

Use Phl-Gabapentin capsules 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 Phl-Gabapentin capsules.

Uses of Phl-Gabapentin in details

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Phl-Gabapentin 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. Phl-Gabapentin 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.

Phl-Gabapentin 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 Phl-Gabapentin

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

Different forms of Phl-Gabapentin (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.

Phl-Gabapentin description

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

Phl-Gabapentin dosage

Phl-Gabapentin Dosage

Generic name: Phl-Gabapentin 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 Phl-Gabapentin interchangeably with other Phl-Gabapentin products.

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

If Phl-Gabapentin 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, Phl-Gabapentin therapy should be initiated and titrated as follows:

Table 1: Phl-Gabapentin Recommended Titration Schedule
Day 1 Day 2 Days 3-6 Days 7-10 Days 11-14 Day 15
Daily Dose 300 mg 600 mg 900 mg 1200 mg 1500 mg 1800 mg

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

Table 2: Phl-Gabapentin Dosage Based on Renal Function
Once-daily dosing
Creatinine Clearance (mL/min) Phl-Gabapentin Dose (once daily with evening meal)
≥ 60 1800 mg
30 - 60 600 mg to 1800 mg
< 30 Phl-Gabapentin should not be administered
patients receiving hemodialysis Phl-Gabapentin should not be administered

More about Phl-Gabapentin (Phl-Gabapentin)

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Professional resources

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Phl-Gabapentin interactions

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What other drugs will affect Phl-Gabapentin?

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There are spontaneous and literature case reports of respiratory depression and/or sedation associated with Phl-Gabapentin and opioid use. In some of these reports, the authors considered this a particular concern with the combination of Phl-Gabapentin 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 Phl-Gabapentin capsule, mean Phl-Gabapentin AUC increased by 44% compared to Phl-Gabapentin 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 Phl-Gabapentin 2 hours after morphine. The observed opioid-mediated side effects associated with morphine plus Phl-Gabapentin did not differ significantly from morphine plus placebo. The magnitude of interaction at other doses is not known.

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

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

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

Renal excretion of Phl-Gabapentin is unaltered by probenecid.

A slight decrease in renal excretion of Phl-Gabapentin 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 Phl-Gabapentin was added to other anticonvulsant drugs. To determine urinary protein, the more specific sulfosalicylic acid precipitation procedure is recommended.

Phl-Gabapentin side effects

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What are the possible side effects of Phl-Gabapentin?

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 Phl-Gabapentin 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

Phl-Gabapentin and 6.9% of 364 patients treated with placebo discontinued prematurely due to adverse reactions. In the Phl-Gabapentin treatment group, the most common reason for discontinuation due to adverse reactions was dizziness. Of Phl-Gabapentin-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 Phl-Gabapentin 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 Phl-Gabapentin-Treated Patients and More Frequent Than in the Placebo Group)

Body System - Preferred Term Phl-Gabapentin

N = 359

%

Placebo

N = 364

%

Ear and Labyrinth Disorders
Vertigo 1.4 0.5
Gastrointestinal Disorders
Diarrhea 3.3 2.7
Dry mouth 2.8 1.4
Constipation 1.4 0.3
Dyspepsia 1.4 0.8
General Disorders
Peripheral edema 3.9 0.3
Pain 1.1 0.5
Infections and Infestations
Nasopharyngitis 2.5 2.2
Urinary tract infection 1.7 0.5
Investigations
Weight increased 1.9 0.5
Musculoskeletal and Connective Tissue Disorders
Pain in extremity 1.9 0.5
Back pain 1.7 1.1
Nervous System Disorders
Dizziness 10.9 2.2
Somnolence 4.5 2.7
Headache 4.2 4.1
Lethargy 1.1 0.3

In addition to the adverse reactions reported in Table 4 above, the following adverse reactions with an uncertain relationship to Phl-Gabapentin 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 Phl-Gabapentin-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 Phl-Gabapentin

In addition to the adverse experiences reported during clinical testing of Phl-Gabapentin, the following adverse experiences have been reported in patients receiving other formulations of marketed Phl-Gabapentin. 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 Phl-Gabapentin immediate release have also been reported. The most frequently reported events were anxiety, insomnia, nausea, pain and sweating.

Phl-Gabapentin contraindications

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What is the most important information I should know about Phl-Gabapentin?

You should not use this medication if you are allergic to Phl-Gabapentin.

Before taking Phl-Gabapentin, tell your doctor if you have kidney, liver, or heart disease.

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

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



Active ingredient matches for Phl-Gabapentin:

Gabapentin


Unit description / dosage (Manufacturer)Price, USD
Capsule; Oral; Gabapentin 100 mg
Capsule; Oral; Gabapentin 300 mg
Capsule; Oral; Gabapentin 400 mg
Tablet; Oral; Gabapentin 600 mg
Tablet; Oral; Gabapentin 800 mg
Capsules; Oral; Gabapentin 100 mg
Capsules; Oral; Gabapentin 300 mg
Capsules; Oral; Gabapentin 400 mg
Tablets; Oral; Gabapentin 600 mg
Tablets; Oral; Gabapentin 800 mg
PHL-gabapentin tablet 600 mg (Pharmel Inc (Canada))
PHL-gabapentin tablet 800 mg (Pharmel Inc (Canada))

List of Phl-Gabapentin substitutes (brand and generic names):

Capsule; Oral; Gabapentin 100 mg (Pharmascience)
Capsule; Oral; Gabapentin 300 mg (Pharmascience)
Capsule; Oral; Gabapentin 400 mg (Pharmascience)
Tablet; Oral; Gabapentin 600 mg (Pharmascience)
Tablet; Oral; Gabapentin 800 mg (Pharmascience)
PMS-Gabapentin 300 mg x 10's (Pharmascience)
PMS-Gabapentin 300 mg x 10 x 10's (Pharmascience)
PMS-Gabapentin 400 mg x 10's (Pharmascience)
PMS-Gabapentin 400 mg x 10 x 10's (Pharmascience)
PMS-Gabapentin 100 mg x 1's (Pharmascience)
PMS-Gabapentin 300 mg x 1's (Pharmascience)
PMS-Gabapentin 400 mg x 1's (Pharmascience)
Capsules; Oral; Gabapentin 100 mg (Pharmascience)
Capsules; Oral; Gabapentin 300 mg (Pharmascience)
Capsules; Oral; Gabapentin 400 mg (Pharmascience)
Tablets; Oral; Gabapentin 600 mg (Pharmascience)
Tablets; Oral; Gabapentin 800 mg (Pharmascience)
PMS-Gabapentin cap 100 mg 100's (Pharmascience)
PMS-Gabapentin cap 300 mg 100's (Pharmascience)
PMS-Gabapentin cap 400 mg 100's (Pharmascience)
PMS-Gabapentin cap 300 mg 10's (Pharmascience)
PMS-Gabapentin cap 300 mg 10 x 10's (Pharmascience)
PMS-Gabapentin cap 400 mg 10's (Pharmascience)
PMS-Gabapentin cap 400 mg 10 x 10's (Pharmascience)
PMS-gabapentin capsule 400 mg (Pharmascience)
PMS-gabapentin tablet 800 mg (Pharmascience)
PMS-gabapentin capsule 100 mg (Pharmascience)
PMS-gabapentin tablet 600 mg (Pharmascience)
PMS-gabapentin capsule 300 mg (Pharmascience)
Priva-gabapentin capsule 100 mg (Pharmapar Inc (Canada))
Priva-gabapentin tablet 600 mg (Pharmapar Inc (Canada))
Priva-gabapentin capsule 300 mg (Pharmapar Inc (Canada))
Priva-gabapentin tablet 800 mg (Pharmapar Inc (Canada))
Priva-gabapentin capsule 400 mg (Pharmapar Inc (Canada))
Capsule; Oral; Gabapentin 100 mg
Capsule; Oral; Gabapentin 300 mg
Capsule; Oral; Gabapentin 400 mg
Tablet; Oral; Gabapentin 600 mg
Tablet; Oral; Gabapentin 800 mg
Capsules; Oral; Gabapentin 100 mg
Capsules; Oral; Gabapentin 300 mg
Capsules; Oral; Gabapentin 400 mg
Tablets; Oral; Gabapentin 600 mg
Tablets; Oral; Gabapentin 800 mg
Pro-gabapentin capsule 300 mg (Pro Doc Limitee (Canada))
Pro-gabapentin capsule 400 mg (Pro Doc Limitee (Canada))
Pro-gabapentin tablet 600 mg (Pro Doc Limitee (Canada))
Pro-gabapentin tablet 800 mg (Pro Doc Limitee (Canada))
Pro-gabapentin capsule 100 mg (Pro Doc Limitee (Canada))
Progaba 100mg TAB / 10 (Mesmer (Icon))$ 0.52
Progaba 300mg TAB / 10 (Mesmer (Icon))$ 1.45
PROGABA 100 MG TABLET 1 strip / 10 tablets each (Mesmer (Icon))$ 0.59
PROGABA 300 MG TABLET 1 strip / 10 tablets each (Mesmer (Icon))$ 1.59
PROGABA tab 100 mg x 10's (Mesmer (Icon))$ 0.52
PROGABA tab 300 mg x 10's (Mesmer (Icon))$ 1.33
Progaba 100mg Tablet (Mesmer (Icon))$ 0.06
Progaba 300mg Tablet (Mesmer (Icon))$ 0.16
Progaba Gel (Mesmer (Icon))$ 2.17
Progaba-AM Gabapentin 300 mg, pyridoxine10 mg, thiamine 25 mg, mecobalamin 500 mcg. TAB / 10 (Mesmer (Icon))$ 1.45
PROGABA-AM tab 10's (Mesmer (Icon))$ 1.42

References

  1. 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).
  2. PubChem. "gabapentin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "gabapentin". http://www.drugbank.ca/drugs/DB00996 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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