gabapentin

Benzodiazepines and Other Central Nervous System (CNS) Depressants Due to additive pharmacologic effect, the concomitant use of benzodiazepines and other CNS depressants such as benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.

Mechanism: Both of these drugs slow down the central nervous system. Taking them together can cause extreme sleepiness, dangerously slow breathing, coma, or even death.

What to do: Use these drugs together only if your doctor says it is absolutely necessary. Monitor closely for signs of extreme drowsiness or trouble breathing.

7 DRUG INTERACTIONS Concentrations increased by morphine; may need dose adjustment (5.4, 7.1 ) 7.1 Opioids Respiratory depression and sedation, sometimes resulting in death, have been reported following coadministration of gabapentin with opioids (e.g., morphine, hydrocodone, oxycodone, buprenorphine) [ see Warnings and Precautions (5.7) ]. 7.1 Opioids Respiratory depression and sedation, sometimes resulting in death, have been reported following coadministration of gabapentin with opioids (e.g., morphine, hydrocodone, oxycodone, buprenorphine) [ see Warnings and Precautions (5.7) ].

Mechanism: Both of these medications slow down the central nervous system, which can lead to dangerous breathing problems and extreme sleepiness. Taking them together increases the risk of these life-threatening side effects.

What to do: Your doctor should monitor you closely for signs of breathing trouble and may need to adjust your dosages.

Oral Contraceptive Based on AUC and half-life, multiple-dose pharmacokinetic profiles of norethindrone and ethinyl estradiol following administration of tablets containing 2.5 mg of norethindrone acetate and 50 mcg of ethinyl estradiol were similar with and without coadministration of gabapentin (400 mg three times a day; N=13).

Mechanism: Based on clinical studies, gabapentin does not change how the body processes or reacts to birth control hormones like estradiol. There is no significant interaction between these two drugs.

What to do: No special dose changes are usually needed when taking these two medications together.

Naproxen Coadministration (N=18) of naproxen sodium capsules (250 mg) with Gabapentin (125 mg) appears to increase the amount of gabapentin absorbed by 12% to 15%. Gabapentin had no effect on naproxen pharmacokinetic parameters.

Mechanism: Taking naproxen can cause the body to absorb a slightly higher amount of gabapentin than it normally would. This could potentially increase the effects or side effects of the gabapentin.

What to do: Your doctor may need to monitor you for increased side effects if you take these medications at the same time.

Oral Contraceptive Based on AUC and half-life, multiple-dose pharmacokinetic profiles of norethindrone and ethinyl estradiol following administration of tablets containing 2.5 mg of norethindrone acetate and 50 mcg of ethinyl estradiol were similar with and without coadministration of gabapentin (400 mg three times a day; N=13). The C max of norethindrone was 13% higher when it was coadministered with gabapentin; this interaction is not expected to be of clinical importance.

Mechanism: Gabapentin slightly raises the peak level of the birth control hormone in your blood, but the change is very small.

What to do: No changes are needed because this small increase is not expected to cause any problems.

Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

The Harvard Drug Group LLC

Defective container; blister packaging inadequately sealed.

The Harvard Drug Group LLC

CGMP Deviations

Glenmark Pharmaceuticals Inc., USA

Cross Contamination

SUN PHARMACEUTICAL INDUSTRIES INC