Download crampfort : prescribing information

CRAMPFORT
Indications:
CRAMPFORT is indicated for the treatment of severe or constant leg cramps in pregnant
women in their 2nd and 3rd trimester.
Dosage and administration:
One sachet once a day after dissolving in half glass of water.
Missed Dose:
If a dose is missed, an extra dose should not be taken. The usual schedule should be
resumed.
Overdosage:
No specific information is available on the treatment of over dosage with CRAMPFORT.
Treatment is symptomatic and supportive.
FDA Category in pregnant women:
 Levocarnitine - Studies in rats and rabbits at levocarnitine doses up to 3.8 times
the usual adult dose (based on body surface area (mg/m2)) have not demonstrated
impaired fertility or fetal harm. FDA Pregnancy Category B.
 MgSO4 – Belongs to category A or B.
 Vitamin B5 – Belongs to category A, hence can assumed to be safe during
pregnancy.
 Calcium – Category C
Adverse reactions
 Levocarnitine –
Those indicating need for medical attention
Incidence more frequent
Hypertension — in dialysis patients with end-stage renal disease (ESRD)
Incidence less frequent
o Fever — in dialysis patients with ESRD
o tachycardia (fast heartbeat)— in dialysis patients with ESRD
Incidence rare
o Seizures — may occur in patients with or without seizure history;
increased seizure frequency and/or severity has been reported in patients
with pre-existing seizure activity
Incidence more frequent
o Abdominal or stomach cramps
o diarrhea
o headache —in dialysis patients with ESRD
o nausea or vomiting


Magnesium Sulphate - Flushing, sweating, hypotension, depression of reflexes,
flaccid paralysis, hypothermia, circulatory collapse, depression of cardiac
function, CNS depression.
Vitamin B5 – Dermatologic (Rash) and GI (Diarrhea at large doses).
Contraindications:



Subjects who are hypersensitive to this drug or to any ingredient in the
formulation or component of the container.
Vitamin E is contraindicated in anti-coagulation therapy
Conditions like: Intracranial Hemorrhage, CVA, and Closed Head Injury
Warnings and precautions:
 Levocarnitine – Caution in case of any seizure disorder and renal impairment.

MgSo4 - Use with caution if flushing and sweating occurs.
Drug interactions:
 Levocarnitine: Valproic acid (requirements for carnitine may be increased in
patients receiving valproic acid). Ginkgo biloba combination may increase risk of
seizures (additive effects).
 MgSO4 - Administer with caution to patients receiving digitalis glycosides.
Effects of neuromuscular blocking agents may be enhanced. Magnesium sulphate
should not be administered concomitantly with high doses of barbiturates, opioids
or hypnotics due to the risk of respiratory depression.
 Vitamin B5 – Biotin Life-threatening eosinophilic pleuropericarditis has been
reported with concurrent use.
Storage: Store in a cool, dry and dark place. Protect from light and moisture.
Presentation: Sachet containing 15 gm powder.