Pregabalin - @ - Anticonvulsants- (FDC- List )- (May 2006)
Drug Name:Pregabalin - @ - Anticonvulsants- (FDC- List )- (May 2006)
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Interaction with Food
Pregnancy and lactation
Drug Interaction:
Clinically no relevant pharmacokinetic interactions were observed between
Progabalin and phenytoin, carbamazepine, valproic acid ,lamotrigine, gabapentin,
lorazepam, oxycodone or ethanol
Oral antidiabetics, diuretics,insulin, phenobarbital, tiagabine and topiramate
had no clinically significant effect on pregablin clearance
Coadmin of oral contraceptives norethisterone and or ethinyl oerstradiol
does not influence influence the steady state pharmacokinetics of either substance
Pregabalin may potentiate the effects
of ethanol and lorazepam.
Indication:
U.S.FDA DRUGS APPROVED FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
125. Pregablin capsules 29-04-08
(Addl.indication)
Management of fibromyalgia syndrome
126. Pregablin 75mg/150mg 08-05-08
+ Methylcobalamin 750mcg
(Addl.stgth)
same as approved
U.S.FDA APPROVED DRUGS DURING 2006
46. Pregablin Capsule 25/50/100/200mg 19-05-2006
(addl.stgth)
Same as approved
U.S FDA APPROVED DRUGS DURING 2007
182. Pegabalin 75mg/150mg + 12-10-07
Methylcobalamine 500mcg capsules
For the treatment of adult patients with
peripheral neuropathy
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Pregablin 150mg/75mg 12-10-2010
+Methylcobalamin 750mcg
+Alpha Lipoic acid 100mg
+Pyridoxine 3mg
+Folic acid 1.5mg capsules
For the treatment of Painful Diabetic Neuropathy in adults only
2.Pregablin 75mg/150mg 08-05-2008
+Methylcobalamin 750mcg Capsules
(Addl.Stgth)
Same as approved
3.Pregablin Capsules 25/50/100/200mg 19-05-2006
(Addl.stgth)
Same as approved
4.Pregablin capsules 29-04-2008
(Addl.Indication)
Management of Fibromyalgia syndrome
5.Pregablin SR 75/150/300mg 09-02-2010
+ Methylcobalamin 1500cg tablets
For the treatment of adult patients with Peripheral Neuropathy
6.Pregablin SR Tablet 150mg/300mg 16-05-2009
For the treatment of Peripheral Neuropathic pain in adults
7.Pregablin SR tablets 75mg 30-10-2010
(Addl.Stgth)
Same as approved
8.Pregablin 75mg/150mg 12-10-2007
+ Methylcobalamine 500mcg capsules
For the treatment of Adult patients with peripheral neurapathy
Peripheral neuropathic pain in adults
Adverse Reaction:
Infections and infestations - uncommon - nasopharyngitis
Blood or lymphatic system disorders- rare- neutropenia
Metabolism and nutrional disorders-
Common - appetite increased.
Uncommon - anorexia
Rare- Hypoglycemia
Psychiatric disorders-
Common- Confusion, disorientation, irritability, euphoric, mood, libido decreased
insomnia
Uncommon- Depersonalisation,anorgasmia, restlessness, depression,agitation,
mood swings, depressed moods, word finding difficulty, hallucinations,
abnormal dreams, libido increased, panic attacks, apathy
Rare- Disinhibition, elevated mood
Nervous sysyem disorders-
Very common- Dizziness, somlolence
Common- Ataxia, coordination, abnormal balance disorder, amnesia, disturbance
in attention, memory impairment, tremor, dysarthia, paresthesia, sedation,
lethargy
Uncommon- Conginitive disorder, hypoesthesia, hystagmus,speech disorder, myoclonus, hyporeflexia, dyskinesia, psychomotor hyperactivity, dizziness postural, hyperesthnia, ageusia, burning sensation, intension tremor, stupor, syncope
Rare- Hypokinesia, patosmia, dysgraphia
Eye Disorders-
Common- Vision blurred, diplopia
Uncommon- Visual disturbances, visual field defect,dry eye, eye swelling, visual acuity,
eye pain, asthenopia, lacrimation increased
Rare- Photopsia, eye irritation, mydriasis, oscillopsia, altered visual depth, perception,
perpheral vision loss, strabismus, visual brighness
Ear and labyrinth disorders-
Common- Vertigo
Uncommon- Hyperacusis
Cardiac disorders-
Uncommon- Atrioventricular block first degree, tachcardia
Rare- Sinus tachycardia, sinus arrhthmias, sinus bradycardia
Vascular disorders-
Uncommon- Hypotension,flushing, hotflushes, peropheral coldness
Respiratory , throaic and mediastinal disorders-
Uncommon- Dyspnoea, cough, nasal dryness
Rare- Nasal congstion, epistaxis, rhinitis, snoring, throat tightness
Gastrointestinal disorders
Common- Vomiting, abdominal distention, constipation, dry mouth, flatulence
Uncommon- Salivary hypersecretion, gastrooestrophagus reflux discease,
hypoethesia oral
Rare- Acites, dysphagia, pancreatitis
Skin and subcutaneous tissue disorders-
Uncommon- sweating, rsh popular
Rare- Cold sweat, urticaria
Musculoskeletal and connective tissue disorders-
Uncommon- Muscle twitching, joint swellling, muscle cramps, myalgia, arthalgia,
back pain, pain in limb, muscle stiffness
Rare- Cervical spasm, neck pain, rhabdomyolysis
Renal and urinary disorders-
Uncommon- Dysuria, urinary incontinence
Rare- Oliguria, renal failure
Reproductive system and breast disorders-
Common- Erection dysfunction
Uncommon- Ejacualtion delayed, sexual dysfunction
Rare- Amenorrhea, breat pain, breast discharge, dysmenorrhea, hypertrophy breast
General disorders and administration site conditions-
Common- Oedema peripheral edema, odema, gait abnormal, feeling drunk,
feeling abnormal, fatigue
Uncommon - chest tightness, fall generalized, pain, chills,asthenia, thirst,
Rare- Pyrexia
Investigations-
Common- Weight increased
Uncommon- Alanine aminotransferase increased, blood cretinine phophokinase
increased, aspartate aminotransferase increased, platelet count decreased
Rare- Blood glucose increased, blood creatinine increased, blood potassium
decreased, weight decreased, white blood count decreased
Contra-Indications:
Hypersensitivity to the substance
Special Precautions-
Galactose Intolerance-Patients with rare heriditary problems of galactose intolerance,
the Lapp lactase deficiency or glucose -galactose malabsorption should not take this medicine
Diabetic patients- Diabetic patients who gain weight on pregabln treatment may need to adjust hpoglycemic medications
Angioedema- Pregabilin should be discontinued immediately if symptoms of angioedema, such as facial, perioral or upper airway swelling occur
Elderly- Pregabalin treatment has been associated with dizziness and somnolence which could increase the occurance of accidental injury (fall) in elderly patients. There are also reports of loss of consciousness, confusion and mental impairment. These patients should be adviced to excercise caution until they are familiar with the potential effects of this medication
Visual changes- Transcient visual blurring and changes in visual acuity have been reported in patients treated with pregablin. Discontinuation of pregabalin may result in resilution or
improvement of these visual symptoms.
Concomittant antiepileptic therapy-There are insufficient data for the withdrawal of concomittant antiepileptic products, once seizure control with pregabalin in the add-on situation has been reached, in order to reach mono-therapy on pregabalin
Discontinuation- Withdraw pregabalin gradually to minimize the potential of increased seizure frequency in patients with seizure disorders.After discontinuation of short-term and long term treatment with pregabalin withdrawal symptoms have observed in some patients. The following
events have been mentioned- insomnia, headache,nausea, anxiety, hyperhidrosis and diarrhea.
Taper pregabilin over a minimum of 1 week rather than discontinue abruptly
Renal Failure-Although the effects of discontinuation on ther revesibilty of renal failure have not been systematically studied improved renal function following discontinuation or dose reduction of pregabalin has been reported
Ability to perform potentially hazardous tasks- Pregabalin may cause dizziness and somnolence and therfore influence the ability to drive or use machines . Patients should be adviced not to drive , operate machinery or engage in otherpotentially hazardous activities
Pregnancy- Pregabalin should not used during pregnancy unless the benefits outweigh the potential risk to the fetus. Efective contraception must be used in women or child bearing potential
Lactation- Breast -feeding is not recommended during treatment with prgabalin
Dosages/ Overdosage Etc:
Date of Approval- 2006
Indication-
Peripheral neuropathic pain in adults
Dosage-
Initially 150mg daily in 2 or 3 divided doses increase if necessary after 1 week to 300mg daily then to maximum of 600mg if needed after a further week.
Not recommended for patients below 18 years
Patient Information:
1. Advice patients that pregabalin may cause angioedema with swelling of the face,
mouth,( lip, gum. tongue ) and neck ( larynx and pharynx ) thart can lead to life threatening
respiratory compromise. Instruct patients to discontinue pregabalin and seek immediate
medical advice.
2 Advice patients that pregabalin may be associated with hypersensitivity reactions,
such as blisters, dyspnea, hives, rash and wheezing . Instruct patients to discontinue
pregabalin and seek medical advice if they experience such symptoms.
3. Counsel patients tht pregabalin may cause blurred vision, dizziness, somnolence, and
other CNS signs and symptoms. Advice them to not to drive , operate complex machinery,
or engage in other hazardous activities while on therapy.
4. Counsel patients that pregabalin may cause visual disturbances. Inform patients to
notify their health care provider if changes in vision occur.
5. Inform patients to promptly report unexplained muscle pain, tendeness or weakness
particularly if accompanied by malaise or fever
6. Inform patients if they require concomittant treatment with CNS depressants such as opiates or benzodiazepines, that they may experience additive CNS adverse reactions such as somnolence
7. Inform patients to avoid consuming alcohol while taking pregabalin because it may
potentiate the impairment of motor skills and sedation of alcohol.
8. Inform patients to notify their doctor if they become pregnant or intend to become pregnant during therapy and also notify their doctor if they are breast feeding or intend to breast feed during therapy
9. Inform diabetic patients to pay particular attention to skin integrity while being treated with
pregabalin.
Pharmacology/ Pharmacokinetics:
Pharmacology-
Pregablin binds with high affinity to alpha2-delta site (an auxiliary subunit of volage-gated calcium channels in CNS tissue. In vitro, pregabalin reduces the calcium channel-dependent release of several neurotransmitters ,possibly by modulation of calcium channel function
Pharmacokinetics-
Pregabalin is well absorbed aftr oral administration. Following oral administration of pregabalin under fasting conditions , peal plama concentration is reached within 1.5 hr . Pregabalin oral bioavailability is 90% or more and is independent of dose.
Interaction with food-Rate of pregabalin absorption is decreased when given with food resulting in a Cmax of approximately 25% to 30% and an increase in time of maximal concentration Tmax to
approximately 3 hours.
Interaction with Food:
Rate of pregabalin absorption is decreased when given with food resulting in a Cmax of
approximately 25% to 30% and an increase in time of maximal concentration Tmax to
approximately 3 hours.
Pregnancy and lactation:
Pregnancy-
Pregabalin should not used during pregnancy unless the benefits outweigh the potential
risk to the fetus. Efective contraception must be used in women or child bearing potential
Lactation-
Breast -feeding is not recommended during treatment with prgabalin
