MONO MACK 20MG TAB; isosorbide mononitrate, cardiovascular agents .
ACTIVE-INGREDIENT OF MONO MACK 20MG TAB
Each tablet contains: Isosorbide mononitrate 20 mg & lactose 80 mg.
INDICATION OF MONO MACK 20MG TAB
Prophylactic treatment of Angina Pectoris.
DOSAGE OF MONO MACK 20MG TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
Adults: The usual dose of Monomak is 1 tablet of Monomak 20 mg, taken asymmetrically (to allow a nitrate low period) 2 to 3 times daily. If result is not adequate, the dose may be increased to 1 tablet of Monomak 40 mg taken asymmetrically (to allow a nitrate low period) 2 to 3 times daily. The dosage may be increased to 120 mg per day. Dosage regime should be designed according to the clinical response of the patient. The lowest effective dose should be used. In patients taken Monomak twice daily, the second dose should be taken 8 hours after the 1st dosage. If the dose is one three times daily, take one every 6 hours. This provides a nitrate-free period of 6 – 8 hours. The maximum dose is 3 tablets Monomak 40 mg per day. In order to prevent possible initial undesirable effect, it may be adequate to initiate treatment with possible lowest dose and slowly increase to the required dose. To prevent tolerance, it is recommended that the dosage be kept as low as possible and that a sufficiently long nitrate-free interval is ensured to restore sensitivity (first dose in the morning and last dose late in the afternoon, e.g. at 8 am and 3 pm). The duration of application is decided by the treating physician. Treatment with Monomak, as with any other nitrate, should not be stopped suddenly. Both the dosage and frequency should be tapered gradually. Elderly: There is no evidence to suggest that an adjustment of the dosage is necessary in elderly. Pediatric population: There is as yet no data on the safety and efficacy of Monomak in children. For oral administration. Method of administration: The tablet should be swallowed whole, taken after meals. It should be unchewed with little fluid.
OVER-DOSAGE OF MONO MACK 20MG TAB
Human experience: Signs and symptoms: Headache, hypotension (fall in blood pressure ≤ 90 mmHg), paleness, nausea, vomiting, sweating, weak pulse, tachycardia, light-heasedness of standing, weakness, dizziness, anxiety, hot and red skin, blurred vision, syncope, diarrhoea. An increase in intracranial pressure with confusion and neurological deficit occurs uncommonly. In very high doses the intracranial pressure may be increased. This may lead to cerebral symptoms. Methaemoglobinaemia (cyanosis, hypoxaemia, agitation, respiratory depression, convulsions, cariac arrhythmias, circulatory insufficiency, increased intracranial pressure) occurs rarely. Methaemoglobinaemia has been reported in patients receiving other organic nitrates. During Monomak biotransformation nitrite ions are released, which may induce methaemoglobinaemia and cyanosis with subsequent tachypnoea, anxiety, loss of consciousness and cariac arrest. It cannot be excluded than an overdose of Monomak may cause this adverse reaction. Treatment: The following treatments are intended only as guidlines and are at the discretion of the treating physician. General procedure: Stop using Monomak. Consider absorption-reducing therapy (administartion of activated charcoal) and in case of suspected severe intoxication consider flushing of the stomach (where practicable within one hour after ingestion). General procedure in case of incident of nitrate-related low blood pressure: Put the patient in horizontal position with the legs up and lower the head. Give oxygen. Expand plasma volume (I.V.fluids). Specific treatment for shock (admit patient to intensive care unit ). Special procedure: Raising the blood pressure if the blood pressure is very low. Treatment of methaemoglobinaemia. Reduction therapy of choice with vitamin C, methylene-blue or toluidine-blue. Administer oxygen (if necessary). Initiate artificial ventilation. Hemodialysis (if necessary). Resuscitation measures. In case of persistent hypotension: Administration of norepinephrine HCl or dopamine. Treatment of methemoglobinemia: Adminstration of antidote: methylene blue: up to 50 ml of a 1% solution i.v.; vitamin C; 1 g p.o. or as sodium salt i.v; toludine blue: initially 2 – 4 mg/kg body weight strictly i.v.; if necessary repeated several times with a time lag of one hour with 2 mg/kg body weight. If necessary, apply artigicial respiration. In severe refractory methemoglobinemia (metHEB> 70%) consider hemodialysis, exchange tranfusion. In case of signals of a respiratory and circulatory arrest, start reanimation immediately.
CONTRA-INDICATION OF MONO MACK 20MG TAB
Hypersensitivity to the Monomak or to any of the excipients . Monomak should not be used in cases of acute myocardial infarction with low filling pressure, acute circulatory failure (shock, vascular collapse), or hypertrophic obstructive cardiomyopathy (HOCM), constrictive pericarditis, low cardiac filling pressures, aortic/mitral valve stenosis and diseases associated with a raised intra-cranial pressure e.g. following a head trauma and including cerebral haemorrhage. Monomak should not be used in patients with severe anaemia, severe hypotension, closed angle glaucoma or severe hypovolaemia. Phosphodiesterase type-5 inhibitors (eg sildenafil, tadalafil and vardenafil) have been shown to potentiate the hypotensive effects of nitrates, and their co-administration with nitrates or nitric oxide donors is therefore contraindicated.
STORAGE OF MONO MACK 20MG TAB
Stored at temperature not exceeding than 30 °C. in dry place. Store in the original pack.
PACK OF MONO MACK 20MG TAB
Carton box containing 2 (Aluminium/Transparent PVC) strips each of 10 tablets & contains inner leaflet.
MONO MACK 20MG TAB MANUFACTURED BY
October Pharma S.A.E. 6 October City – Egypt