The use of this product caries with it an associated risk of psychological and/or physical dependence.
The use of this product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving or operating machinery.
Use of this product with alcohol may result in additional central nervous system depressant effects.
Tell your doctor or pharmacist if you also take antihistamines, anti-seizure drugs, medicine for sleep or anxiety, muscle relaxants, narcotic pain relievers, or psychiatric medicines.
This drug may increase the risk for heatstroke because it decreases sweating. Avoid becoming overheated in hot weather, saunas, and during exercise or other strenuous activity.
- voriconazole
- pramlintide.
This medicine may also interact with the following medication:
CNS depressants
cyclosporine
female hormones, like estrogens or progestins and birth control pills
medicines for HIV infection like indinavir, nelfinavir, ritonavir, and saquinavir
warfarin
amantadine
anti-Parkinson's drugs levodopa, benztropine, trihexphenidyl
antispasmodic drugs clidinium, dicyclomine, propantheline
MAO inhibitors furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcpromine
anti-arrhythmic drugs disopyramide, procainamide, quinidine
azole anti-fungal drugs ketoconazole, itraconzole
bisphosphonate drugs alendronate, risedronate
corticosteroid prednisone
digoxin (slow-dissolving tablets)
phenothiazines (Promethazine)
potassium tablets/capsules
anti-seizure drug carbamazepine
anti-anxiety drugs alprazolam, diazepam, zolpidem
narcotic pain relievers
psychiatric drugs chlorpromazine, haloperidol, amitriptyline,risperidone
certain antihistamines diphenhydramine, meclizine
muscle relaxants
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:
Long-term studies in animals have not been performed to evaluate carcinogenic potential.
PREGNANCY TERATOGENIC EFFECTS:
Pregnancy Category D.
Quadrapax Elixir
can cause fetal harm when administered to a pregnant woman. Retrospective case-controlled studies have suggested a connection between the maternal consumption of phenobarbital and higher than expected incidence of fetal abnormalities. Following oral administration, phenobarbital readily crosses the placental barrier and is distributed throughout fetal tissues with highest concentrations found in the placenta, fetal liver, and brain. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
NONTERATOGENIC EFFECTS:
Reports of infants suffering from long-term phenobarbital exposure in utero included the acute withdrawal syndrome of seizures and hyperirritability from birth to a delayed onset of up to 14 days.
LABOR AND DELIVERY:
Administration of
Quadrapax Elixir
to the mother during labor may result in respiratory depression in the newborn. Premature infants are particularly susceptible to the depressant effects.
NURSING MOTHERS:
Caution should be exercised when
Quadrapax Elixir
is administered to a nursing woman. The active ingredients contained in this drug product are known to be excreted in human milk.
SPECIAL PATIENT POPULATION:
Dosage should be reduces in the debilitated because these patients may be more sensitive to phenobarbital. Dosage should be reduced for patients with impaired renal function or hepatic disease.
PEDIATRIC USE:
Use
Quadrapax Elixir
with caution in children as they may be more susceptible to the effects of this product especially infants, children with Down's syndrome, spastic paralysis or brain damage.
GERIATRIC USE:
Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of
Quadrapax Elixir
and observed closely. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
