Co Valtin 5/80 - Tablet Amlodipine + Valsartan - 5mg+80mg 1 Tablet(s) / Tablet The ACME Laboratories Ltd. Introduction: Co Valtin 5/80 contains two medicines, both of which help to control high blood pressure. It lowers the blood pressure by relaxing the blood vessels and making it easier for your heart to pump blood around your body. This will reduce your risk of having a heart attack or a stroke. Co Valtin 5/80 may be taken on an empty stomach or along with food. However, it is better to take it regularly at a fixed time each day, as prescribed by your doctor. The dose will depend on your condition and how you respond to the medicine. It's important... Uses of Co Valtin 5/80: Hypertension (high blood pressure) Side effects of Co Valtin 5/80: HeadacheDizzinessAnkle swellingTirednessPalpitationsIncreased potassium level in bloodSleepinessTaste changeFlushing (sense of warmth in the face, ears, neck and trunk)Upset stomach How to use Co Valtin 5/80: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Co Valtin 5/80 may be taken with or without food, but it is better to take it at a fixed time. How Co Valtin 5/80 works: Co Valtin 5/80 is a combination of two medicines: Amlodipine and Valsartan, which lowers blood pressure effectively. Amlodipine is a calcium channel blocker (CCB) and Valsartan is an angiotensin receptor blocker (ARB). They work by relaxing the blood vessels and making the heart more efficient at pumping blood throughout the body. Indication: Hypertension Initiate with 5 mg/160 mg PO qDay OR Substitute for individually titrated components May increase dose after at least 2 weeks, not to exceed 10 mg/day amlodipine and 320 mg/day valsartan May be adminsitered concomitantly with other antihypertensive agents Hepatic impairment Not recommended for initial therapy; amlodipine 2.5 mg is not an available strength with available dosage forms for this drug combination Amlodipine: Exposure is increased with hepatic insufficiency, consider decreasing dose Valsartan: Exposure increased with mild-to-moderate hepatic insufficiency does not require dosage adjustment; unknown for severe hepatic impairment Elderly: Since both components of the combination are equally well... Administration: Amlodipine : Plasma concentrations may be elevated w/ CYP3A4 inhibitors (e.g. azole antifungals, ritonavir). Concomitant therapy w/ simvastatin may increase risk of myopathy including rhabdomyolysis. May increase ciclosporin plasma levels and conivaptan. Valsartan : May antagonise hypotensive effects and increase the risk of renal impairment w/ NSAIDs. Increased risk of hyperkalaemia w/ K-sparing diuretics, K supplements or K-containing salt substitutes. Potentially Fatal: Increased risk of hypotension, hyperkalemia and changes in renal function (including acute renal failure) when used w/ aliskiren in patients w/ diabetes and renal impairment (GFR <60 mL/min). Adult Dose: Impaired liver or renal function, CHF, sick-sinus syndrome, severe ventricular dysfunction, hypertrophic cardiomyopathy, severe aortic stenosis. Caution when used in patients with idiopathic hypertrophic subaortic stenosis. Elderly, children. During the second and third trimesters of pregnancy, these drugs have been associated with fetal injury that includes hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death Lactation: discontinue drug or do not nurse Child Dose: Pregnancy Category: C (1st trimester); D (2nd & 3rd trimesters). Renal Dose: Amlodipine relaxes peripheral and coronary vascular smooth muscle. It produces coronary vasodilation by inhibiting the entry of Ca ions into the slow channels or select voltage-sensitive channels of the vascular smooth muscle and myocardium during depolarisation. It also increases myocardial oxygen delivery in patients w/ vasospastic angina. Valsartan, an angiotensin II type 1 (AT1) receptor antagonist, produces its BP lowering effects by inhibiting angiotensin II-induced vasoconstriction, aldosterone release and renal reabsorption of Na. Mode of Action: May be taken with or without food. Precaution: Hypertension Side Effect: Renal impairment Mild or moderate (CrCl >30 mL/min): Dose adjustment not necessary Severe (CrCl <30 mL/min): Not studied Pregnancy Category Note: >10% Headache,Increased BUN (6-17%) 1-10% Peripheral edema (5-8%),Anxiety (3%),Nasopharyngitis (4%),Increased potassium (3%),Upper respiratory infection (3%),Dizziness (2%),Somnolence (3%),Diarrhea (3%),Nausea (3%),Abdominal pain (3%),Cough (2%) <1% Orthostatic hypotension,Syncope,Visual disturbance,Tinnitus,Exanthema Potentially Fatal: Hypotension, bradycardia, conductive system delay and CCF. Interaction: Known hypersensitivity to dihydropyridines.