Drug Interaction:
Drug interactions -summary
CYP3A4 inhibitors eg clarithromycin, indinavir, itraconazole, ketoconazole,ritonavir- + Conivinaptan
coadministration of convinaptan and these agents is contraindicated
Convinaptan + CYP3A4 substrates eg. amlodipine, atorvastatin, convastatin, midazolam ,
simavastain-
convinaptan is a potent inhibitor and may increase plasma concentration of coadministred drugs
that are primarily metabolized by CYP3A4
Conivaptan + Digoxin-
coadministration of convinaptan and digoxin resulted in 30% redution in clearance and a
79% increase in digoxin Cmax and AUC values respy.
Indication:
Euvolemic and hypervolemic hypernatremia
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Convipatan Hcl injection 20mg/ml 21-08-2012
For the treatment of euvolemic hyponatremia eg syndrome of
inappropiate secretion of antiduretic hormone or in the setting
of hypothyroidism , Adrenal insufficiency, Pulmonary disorders etc.
in hospitazed patients
Adverse Reaction:
Cardiovascular- atrial fibrilation 2% ECG ST segment depression 5%
hypertension NOS 8% hypotension NOS 8%
orthostatic hypotension 13%
CNS - headache 7% insominia 5%
GI- constipation 8% nausea 3% post-procedural diarrhea 5%
thirst 3% vomiting 5%
Local- infusion site phebitis 51% infusion reaction 22%
Metabolic/nutrional - hypokalemia 22% hypomagnesimia 5% hyponatremia 8%
Respiratory - pharyngeal pain 5% pneumonia 5%
Miscellaneous- Anemia NOS 5% peripheral edema 3% pruritus 5% pyrexia 11%
urinary tract infection NOS 5%
Contra-Indications:
Coadministration with potent CYP3A4 eg ketoconazole, clarithromycin,ritonavir
Special Precaution-
Congestive heart failure- conivaptan is not indicated for treatment of patients with congestive
heart failure. Only use convinaptan for treatment of hyponatremia in patients with underlying
heart failure when the expected clinical benifit of raising serum sodium outweighs increased
risk of adverse reactions for heart patients
Rapid correction of serum sodium- ostmotic demyelination syndrome has been reported following
rapid correction of low serum concentration
Renal function impairment- excercise caution when administering convinaptan to patients
with renal function impairment
Hepatic function impairment- excercise caution when administering convinaptan to patients
with renal function impairment
Pregnancy- appraise patients of the potential hazard to the fetus.
Lactation- excercise caution when convinaptan is administred to breast feeding woman.
Children- safety and efficacy of convinaptan in children have not been studied
Monitoring- patients receiving convinaptan must have frequent monitoring of serum sodium,
neurologic status.
Dosages/ Overdosage Etc:
Indication-
Euvolemic and hypervolemic hypernatremia
Dosage-
The loading dose should be followed by conivaptan 20mg administred as a continuous IV infusion
throughout the 24- hour period.
Following the day of treatment convinaptan to be administred for an additional 1 to 3 days
in a continuous infusion of 20mg/day
Patient Information:
1. This medicine may cause light headedness, or fainting. Advice patients not to drive, operate machinery, or do anything else that could be dangerous until they know how they react to this medicine.
2. This medicine may cause harm to the fetus, If the patient may be pregnant, discuss the benefits the risks of using this medicine during pregnancy.
3. It is not known whether this medicine is found in the breast milk. Advice patients to check with their health care provider if they are or will be breast-feeding while using this medicine and to discuss any possible risks to the baby.
Pregnancy and lactation:
Pregnancy-
Appraise patients of the potential hazard to the fetus.
Lactation-
Excercise caution when convinaptan is administred to breast feeding woman.
Children-
Safety and efficacy of convinaptan in children have not been studied
Manufacturer Details