Isozine FC Tablet
Isosorbide Dinitrate + Hydralazine Hydrochloride
20mg+37.5mg
ACI Limited
| Pack size | 30's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 15.00 AED |
Indications
Isozine FC Tablet is used for:
Heart Failure
Adult Dose
Heart Failure
One tablet three times a day titrated to a maximum tolerated dose up to two tablets three times a day
Dosage may be decreased to as little as one-half tablet three times a day if intolerable side effects occur.
Efforts should be made to titrate up as soon as side effects subside
Child Dose
Renal Dose
Renal Impairment
There are no studies of renal impairment using Isosorbide Dinitrate + Hydralazine Hydrochloride. No dose adjustment is required for hydralazine or isosorbide dinitrite
Administration
Contra Indications
Allergy to organic nitrates
Concomitant use with PDE-5 inhibitors (eg, avanafil, sildenafil, tadalafil, or vardenafil)
Concomitant use with soluble guanylate cyclase (sGC) stimulators (eg, riociguat)
Precautions
May cause symptomatic hypotension
Symptomatic Lupus Erythematosus Syndromes: Consider discontinuation if clinically appropriate
Myocardial ischemia and angina
Peripheral Neuritis: May be treated with Pyridoxine
Pregnancy-Lactation
Pregnancy
There are no data on use in pregnant women, and insufficient data on its components (hydralazine and isosorbide dinitrate) to assess a drug-associated risk of major birth defects or miscarriage with first trimester use; available published data on hydralazine use in pregnancy during second and third trimesters have not shown association with adverse pregnancy-related outcomes
Pregnant women with heart failure are at increased risk for preterm birth; clinical classification of heart disease may worsen with pregnancy and lead to maternal death and/or stillbirth
Animal data
Hydralazine hydrochloride is teratogenic in mice at 66 mg/kg and possibly in rabbits at 33 mg/kg (2 and 3 times maximum recommended human dose (MRHD) on a body surface area basis)
Isosorbide dinitrate has been shown to cause a dose-related increase in embryo-toxicity (excess mummified pups) in rabbits at 70 mg/kg (12 times the MRHD on a body surface area basis)
Lactation
There are no data on presence of drug in human or animal milk, effects on breastfed infant or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed child from drug or from underlying maternal condition
Interactions
Contraindicated (0)
Serious (4)
lofexidine
lonafarnib
pexidartinib
pretomanid
Adverse Effects
Side effects of Isosorbide Dinitrate + Hydralazine Hydrochloride :
Frequency Not Defined
Isosorbide Dinatrate
Flushing
Hypotension/orthostatic hypotension
Lightheadedness
Palpitations
Rebound hypertension (uncommon)
Syncope
Unstable angina tachyarrhythmia
Dizziness
Headache
Restlessness
Weakness
Nausea
Methemoglobinemia (infrequent)
Hydralazine
Hypotension
Palpitations
Tachycardia
Headache
Neuropathy
Anorexia
Diarrhea
Nausea
Vomiting
Agranulocytosis
Leukopenia
Hepatotoxicity
Chest pain
Dyspnea
Nasal congestion
Mechanism of Action
The mechanism of action underlying the beneficial effects of Isosorbide Dinitrate + Hydralazine Hydrochloride in the treatment of heart failure has not been established.
Isosorbide dinitrate is a vasodilator affecting both arteries and veins. Its dilator properties result from the release of nitric oxide and the subsequent activation of guanylyl cyclase, and ultimate relaxation of vascular smooth muscle.
Several well-controlled clinical trials have used exercise testing to assess the anti-anginal efficacy of chronically-delivered nitrates. In the large majority of these trials, active agents were no more effective than placebo after 24 hours (or less) of continuous therapy.
Attempts to overcome nitrate tolerance by dose escalation, even to doses far in excess of those used acutely, have consistently failed.
Only after nitrates have been absent from the body for several hours is response to nitrates restored.
Hydralazine hydrochloride is a selective dilator of arterial smooth muscle. Animal data suggests that hydralazine may also mitigate tolerance to nitrates.
Note
Isozine FC 20mg+37.5mg Tablet manufactured by ACI Limited. Its generic name is Isosorbide Dinitrate + Hydralazine Hydrochloride. Isozine FC is availble in Bangladesh.
Farmaco BD drug index information on Isozine FC Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.