Zoga 100 Composition, Dose, Use, Side Effect

Zoga 100 is a prescription drug for treating erectile dysfunction (ED). It is composed of Sildenafil. Made by Zim Laboratories ltd, India, it is marketed in Nigeria by KCH consumer healthcare ltd in Lagos State.

Zoga 100

Composition Of Zoga 100

Each film coated tablet contains: Sildenafil Citrate equivalent to Sildenafil 100 mg.

Drug Description

ZOGA 100 tablets, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl-4-methylpiperazine citrate. Sildenafil citrate is a white to off-white powder that is freely soluble in dimethyl formamide, slightly soluble in methanol, with a solubility of 3.5 mg/ml in water and a molecular weight of 666.7.

Sildenafil is an inhibitor of cGMP specific phosphodiesterase type-5 (PDE-5) in the smooth muscle of the pulmonary vasculature, where PDE-5 is responsible for degradation of cGMP. Slidenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation.

Read Also: Can yoyo bitter treat erectile dysfunction (ED) 

In patients with PAH, this can lead to vasodilation of the pulmonary vascular bed and, to a lesser degree, vasodilatation in the systemic circulation. Single oral doses of sildenafil 100 mg administered to healthy volunteers produced decreases in supine blood pressure (mean maximum decrease in systolic/diastolic blood pressure of 8/5 mmHg).

The decrease in blood pressure was most notable approximately to 2 hours after dosing, and was not different from placebo at 8 hours. Similar effects on blood pressure were noted with 25 mg, 50 mg and 100 mg doses of sildenafil, therefore the effects are not related to dose or plasma levels within this dosage range. Larger effects were recorded among patients receiving concomitant nitrates.

Drug Interactions

Nitrates: Concomitant use of sildenafil with nitrates in any form is contraindicated.

Ritonavir and other potent CYP3A Inhibitors: Concomitant use of sildenafil with ritonavir and other potent CYP3A inhibitors is not recommended.

Other Drugs that Reduce Blood Pressure: Alpha-blockers in drug-drug interaction studies, sildenafil (25 mg, 50 mg, or 100 mg) and the alpha-blocker doxazosin (4 mg or 8 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy.

In these study populations, mean additional reductions of supine systolic and diastolic blood pressure of 7/7 mmHg 9/5 mmHg, and 8/4 mmHg, respectively, were observed. Mean additional reductions of standing blood pressure of 6/6 mmHg, 11/4 mmhg and 4/5 mmHg, respectively, were also observed. There were infrequent reports of patients who experienced symptomatic postural hypotension. These reports included dizziness and light-headedness, but not syncope.

Amlodipine: When sildenafil 100 mg oral was coadministered with amlodipine, 5 mg or 10 mg oral, to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic. Monitor blood pressure when coadministering blood pressure lowering drugs with sildenafil.

Indications And Usage Of Zoga 100

Zoga 100 tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when zoga 100 tablets were added to background epoprostenol therapy.

Read Also: Danger of using sex enhancer

Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominantly patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).

Limitation of Use

The efficacy of sildenafil tablets in the treatment of pulmonary arterial hypertension (PAH) has not been adequately evaluated in patients taking bosentan.

Contraindications

Zoga 100 tablets are contraindicated in patients with;

Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension.

Known hypersensitivity to zoga 100 or any component of the tablet. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil.

Warnings And Precautions

Mortality with Pediatric Use: In a long-term trial in pediatric patients with PAH, an increase in mortality with increasing sildenafil dose was observed. Deaths were first observed after about one year and causes of death were typical of patients with PAH. Use of sildenafil, particularly chronic use, is not recommended in children.

Hypotension: Sildenafil has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Before prescribing sildenafil, carefully consider whether patients with certain underlying conditions could be adversely affected by such vasodilatory effects (e.g., patients on antihypertensive therapy or with resting hypotension [BP less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction). Monitor blood pressure when coadministering blood pressure lowering drugs with sildenafil.

Worsening Pulmonary Vascular Occlusive Disease: Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since there are no clinical data on administration of sildenafil to patients with veno-occlusive disease, administration of sildenafil to such patients is not recommended. Should signs of pulmonary edema occur when sildenafil is administered, consider the possibility of associated PVOD.

Hearing Loss: Cases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including sildenafil. In some of the cases, medical conditions and other factors were reported that may have played a role.

In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of sildenafil, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors.

Read Also: All about Vega asia 100

Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including sildenafil. Combination with other PDE-5 Inhibitors: The safety and efficacy of combinations of sildenafil tablets and other PDE-5 inhibitors have not been studied.

Adverse Effect

The following serious adverse events are discussed elsewhere in warning and precautions:

Mortality with pediatric use

Hypotension Vision loss

Hearing loss

Vaso-occlusive crisis

Priapism is prolong erection that occur in few case

Zoga 100 Symptoms Of Overdose And Antidote

In studies with healthy volunteers of single doses up to 800 mg, adverse events were similar to those seen at lower doses but rates and severities were increased. In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and it is not eliminated in the urine.

Dosage And Administration Of Zoga 100

The recommended dose is 100 mg taken, as needed, approximately 1 hour before sexual activity. However, Sildenafil may be taken anywhere from 4 hours to 0.5 hour before sexual activity. Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. The maximum recommended dosing frequency is once per day.