{"id":296,"date":"2022-08-08T09:12:14","date_gmt":"2022-08-08T09:12:14","guid":{"rendered":"https:\/\/opv.vn\/?post_type=product&p=296"},"modified":"2022-08-26T08:53:14","modified_gmt":"2022-08-26T08:53:14","slug":"new-ameflu-night-time-syrup","status":"publish","type":"product","link":"https:\/\/opv.vn\/en\/new-ameflu-night-time-syrup\/","title":{"rendered":"New Ameflu Night Time Syrup"},"content":{"rendered":"

Keep out of the reach of children<\/strong>
\nRead carefully the enclosed insert before use<\/strong>
\nShake well before use<\/strong><\/p>\n

\n

COMPOSITION:<\/strong>\u00a0Each 5 ml syrup contains:<\/p>\n

Composition of active ingredients:<\/strong>
\nPhenylephrine hydrochloride \u2026\u2026\u2026\u2026\u2026\u2026..2.5 mg
\nAcetaminophen \u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026160 mg
\nChlorpheniramine maleate \u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026.1 mg
\nComposition of excipients:<\/strong>
\nPropylen glycol, citric acid, sodium benzoate, glycerin, sorbitol 70%, PEG 400, grape flavor, amaranth red, brilliant blue, sucralose, purified water.<\/p>\n

\n
\n<\/div>\n

DOSAGE FORM:<\/strong><\/p>\n

Syrup
\nViscous, purple, fruit flavor, sweet taste.<\/p>\n

\n
\n<\/div>\n

INDICATIONS:<\/strong><\/p>\n

Temporarily relieves the common cold symptoms: Aches and pains, headache, sore throat, nasal congestion (stuffy), cough, sneezing and runny nose and fever.<\/p>\n

\n

DOSAGE AND ADMINISTRATION:<\/strong><\/p>\n

Administration:<\/strong>
\nFor oral use
\nDosage:<\/strong>
\n\u2013 Children under 4 years of age: Do not use
\n\u2013 Children from 4 to 5 years of age: Do not use unless directed by a doctor.
\n\u2013 Children from 6 to 11 years of age: Take 10 ml, every 4 hours. Do not take more than 50 ml in 24 hours.
\nPhysicians should recommend to patients stop taking this product if any of the following symptoms occurs:
\n\u2013 Nervousness, dizziness, or sleeplessness.
\n\u2013 Pain, nasal congestion or cough gets worse or lasts more than 7 days.
\n\u2013 Fever gets worse or lasts more than 3 days.
\n\u2013 Redness or swelling is present.
\n\u2013 New symptoms occur.
\n\u2013 Recurring cough or cough occurs with fever, rash or headache that lasts.
\nThese could be signs of worsening condition.<\/p>\n

\n
\n<\/div>\n

CONTRAINDICATIONS:<\/strong><\/p>\n

\u2013 The patients who are hypersensitive to any ingredients of this product.
\n\u2013 Patients who are receiving MAOIs (see Drug interaction section).
\n\u2013 Children under 4 years of age.<\/p>\n

\n
\n<\/div>\n

WARNINGS AND PRECAUTIONS FOR USE:<\/strong><\/p>\n

\u2013 Acetaminophen, chlorpheniramine and phenylephrine are all metabolized in the liver. Therefore, it is possile that metabolism of one or more of these product ingredients may be reduced in those with significant hepatic disease. It is suggested that liver function tests be monitored in this patient population. Dosage adjustments may be required, as drug accumulation or prolonged duration of action can occur in patients with hepatic dysfunction.
\n\u2013 This medicine should not be used in patients with closed-angle glaucoma. Increased intraocular pressure may occur from the anticholinergic actions of chlorpheniramine, precipitating an acute attack of glaucoma. In addition, the sympathomimetic actions of phenylephrine can also exacerbate closed-angle glaucoma.
\n\u2013 Do not take with any other acetaminophen-containing products. Do not take with other flu, cold or decongestant products. Immediate medical advice should be sought in the event of an overdose, even if patients feel well.<\/p>\n

Special precaution and warning when using medication containing acetaminophen:<\/strong>
\n\u2013 The doctor must warn the patients about the symptoms of serious skin reactions including: Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), or Lyell Syndrome, acute generalized exanthematous pustulosis (AGEP).
\n\u2013 Patients should stop using acetaminophen and seek physician immediately if rash or other symptoms of skin reaction or hypersensitivity reaction are seen during treatment. Patients with a history of such skin reactions should not take products containing acetaminophen.
\n\u2013 Sometimes, skin reactions including pruritic maculopapular rash and urticaria; other sensitivity reactions including laryngeal edema, angioedema and anaphylactid reactions may occur rarely. Thrombocytopenia, leukopenia and pancytopenia have been associated with the use of p-aminophenol derivatives, especially with prolonged administration of large doses. Neutropenia and thrombocytopenic purpura have been reported with acetaminophen use. Rarely, agranulocytosis has been reported in patients receiving acetaminophen.
\n\u2013 Concurrent use of many products containing acetaminophen, leading adverse effects (such as acetaminophen overdose).
\n\u2013 Acetaminophen should be used with caution in patients with preexisting anemia, hepatic failure, renal failure, alcoholism, chronic malnutrition or dehydration.
\nPhenylephrine hydrochloride:<\/strong>
\n\u2013 Carefully when using in patients with tracheobronchitis asthma, intestinal obstruction, hyperthyroidism situation, benign enlargement of the prostate. When using drugs show appear symptoms of irritation, dizziness, sleep disorder must be discontinued and inform to medical personnel.
\nChlorpheniramine maleate:<\/strong>
\n\u2013 Because anti muscarinic effects need careful when using in patients with prostatic hypertrophy, blocked the urinary tract, blocked pyloric of duodenal, and exacerbated in patients who myasthenia gravis.
\n\u2013 The sedative effect of chlorpheniramine increased when drink alcohol and administered concurrently with other sedatives.
\n\u2013 At risk respiratory tract complications, respiratory insufficiency and apnea in patients with obstructive lung disease or in infants. To be careful in with chronic lung disease, shortness of breath or dyspnea, bronchial asthma.
\n\u2013 At risk cavities in patients treated long time, due to the antimuscarinic effect cause dry mouth.
\n\u2013 Using caution with the elderly (> 60 years) because these people are often hypersensitive to anti-muscarinic effects.
\n\u2013 Children are very sensitive to the side effects and may cause nerve stimulation should be careful when using chlorpheniramine for these patients, especially in children with a history of epilepsy.
\nThis drug contains:<\/strong>
\n\u2013 Sorbitol and sucralose. Patients with rare hereditary problems of galactose intolerance, fructose intolerance or glucose-galactose malabsorption should not take this drug.
\n\u2013 Propylene glycol. May cause alcohol \u2013 like symptoms.
\n\u2013 Amaranth red and brilliant blue, which may cause allergic reactions.
\nThis drug contains 19.5 mg sodium benzoate in each 10 ml which is equivalent to 1.95 mg\/ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).<\/p>\n

\n
\n<\/div>\n

PREGNANCY AND LACTATION:<\/strong><\/p>\n

Pregnancy:<\/strong>
\nOnly used for pregnant women if really necessary, with consideration about the harms caused by drugs. Not recommended for pregnant women last 3 months of gestation.
\nLactation:<\/strong>
\nMust be very cautious when using the drug to breastfeeding, should considered or not authorize breastfeeding or not taking this product, depending on the needed level of medication for the mother.<\/p>\n

\n
\n<\/div>\n

EFFECTS ON ABILITY TO DRIVE AND OPERATE MACHINERY:<\/strong><\/p>\n

Be careful when driving or operating machinery.<\/p>\n

\n
\n<\/div>\n

INTERACTIONS AND INCOMPATIBILITIES:<\/strong><\/p>\n

Interactions:<\/strong>
\n\u2013 The speed of absorption of acetaminophen is reduced by cholestyramine. Therefore, the cholestyramine should not be taken within one hour if maximal analgesia is required.
\n\u2013 The speed of absorption of acetaminophen is increased by metoclopramide and domperidone. However, concurrent use need not be avoided.
\n\u2013 Chronic ingestion of large doses of acetaminophen has been reported to slightly potentiate the effects of coumarin and indanedione-derivative anticoagulants.
\n\u2013 The possibility of severe hypothermia should be kept in mind in patients receiving concomitant phenothiazine and antipyretic therapy (as paracetamol).
\n\u2013 Excessive intake of alcohol for long periods of time may increase the risk of acetaminophen induced hepatotoxicity.
\n\u2013 Anticonvulsants (including phenytoin, barbiturates, carbamazepine), isoniazid, antituberculars may increase the hepatotoxicity of acetaminophen.
\n\u2013 Probenecid may reduce the excretion of acetaminophen and increase the half-life in plasma of acetaminophen.
\n\u2013 Do not take this product when is taking a prescription of monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or parkinson\u2019s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child\u2019s prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
\n\u2013 Concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects.
\n\u2013 Phenylephrine may reduce the efficacy of beta-blocking drugs and antihypertensive drugs (including debrisoquine, guanethidine, reserpine, methyldopa). The risk of hypertension and other cardiovascular side effects may be increased.
\n\u2013 Tricyclic antidepressants (e.g. amitriptyline, imipramine): May increase the risk of cardiovascular side effects with phenylephrine.
\n\u2013 Concomitant use of phenylephrine with ergot alkaloids (ergotamine and methylsergide): Increase the risk of ergotism.
\n\u2013 Concomitant use of phenylephrine with digoxin: Increase the risk of irregular heartbeat or heart attack.
\n\u2013 Concomitant use of phenylephrine with atropine will block the reflex bradycardia that phenylephrine causes.
\n\u2013 Ethanol or hypnotics may increase the CNS inhibition effect of chlorpheniramine
\n\u2013 Chlorpheniramine inhibits phenytoin metabolism and can lead to phenytoin toxicity.
\n\u2013 CYP3A4 inhibitors such as: Dasatinib, Pramlintide increase the concentration or effect of chlorpheniramine.
\n\u2013 It reduces the effect of cholinesterase and betahistidin inhibitors.
\nIncompatibilities:<\/strong>
\nThere is no study on drug incompatibilities. Do not mix this drug with other drugs<\/p>\n

\n
\n<\/div>\n

SIDE EFFECTS:<\/strong><\/p>\n

Common (ADR > 1\/100)
\n\u2013 Nervous: Nervous agitation, restlessness, anxiety, sleeplessness, fatigue, dizziness, chest pain, tremor, paresthesia in the extremities, sleep from light sleep to deep sleep, loss of coordination, headache, mental disorder \u2013 athletes.
\n\u2013 Cardiovascular: hypertension
\n\u2013 Skin: Pale, dark white, cold feeling of skin, hairs feathers erect.
\n\u2013 Anti-muscarinic effects: Dry mouth, thick phlegm, blurred vision, urinary retention facilities, constipation, increased gastroesophageal reflux.
\nUncommon (1\/1000 < ADR < 1\/100)
\n\u2013 Cardiovascular: Hypertension associated pulmonary edema, arrhythmias, bradycardia, periphery vasoconstriction and visceral reduced blood supply to these organs, palpitations.
\n\u2013 Dermatologic: Rash, hypersensitivity reactions (bronchospasm, angioedema and anaphylaxis)
\n\u2013 Gastrointestinal: Nauseas, vomiting, diarrhea, epigastric pain
\n\u2013 Hematologic: Blood dyscrasias (neutropenia, pancytopenia, leukopenia), anemia.
\n\u2013 Renal: Nephropathy, nephrotoxicity with chronic abuse.
\n\u2013 Respiratory: Respiratory depression
\n\u2013 Nervous: Euphoria, hallucinations, paranoid
\nRare (ADR < 1\/1000)
\n\u2013 Skin: Stevens-Johnson syndrome, toxic epidermal necrolysis, Lyell syndrome, acute generalized exanthematous pustulosis.
\n\u2013 Cardiovascular: A drive of myocarditis, bleeding under the pericardial
\n\u2013 Haematological: Agranulocytosis, hypoleukemia, hemolytic anemia, thrombocytopenia
\n\u2013 Miscellaneous: Hypersensitivity reactions, seizures, sweating, myalgia, paresthesia, extrapyramidal side effects, sleep disorder, depression, confusion, ringing in the ears, decreased blood pressure, alopecia.
\nAny adverse drug reactions should be immediately reported to the doctor or pharmacist.<\/p>\n

\n
\n<\/div>\n

OVERDOSE AND TREATMENT:<\/strong><\/p>\n

Acetaminophen:<\/strong>
\nSymptoms:
\nAcetaminophen toxicity may be due to a single toxic dose, or repeated large doses of acetaminophen (eg 7.5 \u2013 10 g daily, for 1-2 days), or for long-term administration. Dose-related hepatic toxicity is the most severe acute toxicity resulting from overdosage and possibly death.
\nNausea, vomiting and abdominal pain (normally settle within 24 hours of ingestion). After 24 hours symptoms may include right subcostal pain and tenderness, usually indicates development of hepatic necrosis. Liver damage is greatest 3-4 days after ingestion and may lead to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death.
\nTreatment:
\nTreatment is based on plasma concentration. Acetylcysteine protects the liver if administered within 24 hr after ingestion (most effective if given within 8 hours). Dose: 140 mg\/kg orally (loading) followed by 70 mg\/kg every 4 hours for 17 doses. Activated charcoal or gastric lavage may be treated to decrease absorption of acetaminophen.
\nPhenylephrine HCl:<\/strong>
\nSymptoms:
\nPhenylephrine overdosage lead to hypertension, headache, convulsions, cerebral haemorrhage, palpitation, systolic, paresthesia. Bradycardic often occurs soon.
\nTreatment:
\nHypertension can be overcome by taking \u03b1-adrenergic blockers such as phentolamin 5-10 mg, intravenously; if necessary, repeatable. Hemodialysis is often not helpful. Attention to symptomatic treatment and general support, medical care.
\nChlorpheniramine maleate:<\/strong>
\nSymptoms:
\nThe estimated lethal dose of chlorpheniramine is 20 to 50 mg\/kg body weight.
\nThe symptoms and signs of overdosage include sedation, paradoxical stimulation of CNS, toxic psychosis, epilepsy, apnoea, convulsion, muscarinic effects, dystonic reactions, cardiac collapse and arrhythmia.
\nTreatment:
\nSymptomatic treatment and support of living function. Should monitor particularly to cardiac, respiratory, renal and hepatic functions, fluid and electrolyte balance.
\nGastric lavage should be performed or emesis with ipecacuanha syrup. After that, activated charcoal and cathartics may be administered to reduce absorption of chlorpheniramine.
\nIf hypotension and arrhythmia should be treated vigorously. Convulsion may be treated with intravenous diazepam or phenytoin. Haemoperfusion may be used in severe cases.<\/p>\n

\n
\n<\/div>\n

PHARMACODYNAMICS:<\/strong><\/p>\n

Pharmacotherapeutic group: Cough and cold preparations
\nATC code: R05
\nAcetaminophen is the active metabolite of phenacetin, exhibits analgesic action by peripheral blockage of pain impulse generation. It produces antipyresis by inhibiting the hypothalamic heat-regulating centre. Acetaminophen is used to relieve pain and reduce fever, it may replace aspirin; however, acetaminophen is ineffectively used to treat inflammation. Acetaminophen has effects to relieve pain and fever about as well as aspirin after an equivalent dose. Acetaminophen reduces body temperature in fever patients but it rarely reduces body temperature in normal people. Acetaminophen has rarely effects on cardiovascular and respiratory system after an oral dose. It has no changes of acid-base balance, it does not cause irritation, stomach bleeding or erosion compared to use of aspirin or salicylate. The toxicity in overdosage with acetaminophen is thought to be the production of a metabolite, N-acetyl-p-benzoquinoneimine in the liver.
\nPhenylephrine hydrochloride has similar effect to \u03b11-sympathetic activity which has direct effect on \u03b11-adrenergic receptors causing vasoconstriction and increased blood pressure. Phenylephrine hydrochlorid cause reflex bradycardia, decreasing circulating blood volume and renal blood flow as well as blood flow to many tissues and organs.
\nThe mechanism of action of phenylephrine on \u03b1-adrenergic is by inhibiting cAMP (cAMP: cyclic adenosin -3\u2019, 5\u2019-monophosphate) production via the inhibition of adenyl cyclase enzyme while the \u03b2-adrenergic action is by simulating adenyl cyclase activity.
\nWhen given in nasal mucous membrane, phenylephrine shrinks local blood vessel thus reducing nasal congestion and sinusitis caused by cold.
\nChlorpheniramine maleate is a first-generation antihistamine. It competes with histamine for H1-receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory tract. Its sedative effects are relatively weak compared to other first-generation antihistamines.<\/p>\n

\n
\n<\/div>\n

PHARMACOKINETICS:<\/strong><\/p>\n

Acetaminophen is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 to 60 minutes after oral dose. Acetaminophen is distributed into most body tissues. It crosses placenta and is present in breast milk. Plasma protein binding is negligible at usual therapeutic concentration but increases with increasing concentrations. The elimination half-time varies from about 1 to 3 hours. Acetaminophen is metabolised predominantly in the liver and excreted in the urine mainly as the glucuronide (about 60-80%) and sulfate (about 20-30%) conjugates. Less than 5% is excreted as unchanged acetaminophen. A minor (below 4%) metabolite is usually produced in very small amounts by cytochrom P450.
\nPhenylephrine hydrochloride is irregularly absorbed from the gastrointestinal tract and undergoes first-pass metabolism by monoamine oxidase in the gut and liver. It is almost entirely excreted in the urine.
\nChlorpheniramine maleate is well absorbed after oral doses, and appears in plasma within 30 to 60 minutes. Peak plasma concentration is achieved within 2.5 to 6 hours after oral. Bioavailability is 25-50%. About 70% chlorpheniramine in the circulation is bound to plasma protein. Chlorpheniramine is rapidly and extensively metabolised, metabolites include desmethy-didesmethyl-clorphenamine, and some substances are unknown. Chlorpheniramine is mainly excreted in the urine as unchanged or metabolized form and in the faeces with a small amount. The half-life is 12-15 hours, and may range 280 to 330 hours in chronic renal impairment.<\/p>\n

\n
\n<\/div>\n

DESCRIPTION OF PACKAGING:<\/strong><\/p>\n

Box of 1 bottle 30 ml syrup. Box of 1 bottle 60 ml syrup.<\/p>\n

\n
\n<\/div>\n

STORAGE, SHELF-LIFE, SPECIFICATION OF DRUG:<\/strong><\/p>\n

Storage<\/strong>: Store at temperature below 30o<\/sup>C, in a dry place, protect from light.
\nShelf-life<\/strong>: 36 months from manufacturing date. Do not use after expiry date.
\nSpecification of drug<\/strong>: Manufacturer\u2019s<\/p>\n

\n
\n<\/div>\n

NAME, ADDRESS OF MANUFACTURER:<\/strong><\/p>\n

OPV PHARMACEUTICAL JOINT STOCK COMPANY<\/strong>
\nNo. 27, 3A Street, Bien Hoa II Industrial Zone, An Binh Ward, Bien Hoa City, Dong Nai Province.
\nTel: (0251) 3992999 Fax: (0251) 3892344<\/p>\n","protected":false},"excerpt":{"rendered":"

\n

COMPOSITION:<\/strong>\u00a0Each 5 ml syrup contains:<\/p>\n

Composition of active ingredients:<\/strong>
\nPhenylephrine hydrochloride \u2026\u2026\u2026\u2026\u2026\u2026..2.5 mg
\nAcetaminophen \u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026160 mg
\nChlorpheniramine maleate \u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026.1 mg
\nComposition of excipients:<\/strong>
\nPropylen glycol, citric acid, sodium benzoate, glycerin, sorbitol 70%, PEG 400, grape flavor, amaranth red, brilliant blue, sucralose, purified water.<\/p>\n","protected":false},"featured_media":273,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_cat":[26],"product_tag":[],"class_list":["post-296","product","type-product","status-publish","has-post-thumbnail","hentry","product_cat-ameflu-cough-and-cold-preparations"],"_links":{"self":[{"href":"https:\/\/opv.vn\/en\/wp-json\/wp\/v2\/product\/296","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/opv.vn\/en\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/opv.vn\/en\/wp-json\/wp\/v2\/types\/product"}],"replies":[{"embeddable":true,"href":"https:\/\/opv.vn\/en\/wp-json\/wp\/v2\/comments?post=296"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/opv.vn\/en\/wp-json\/wp\/v2\/media\/273"}],"wp:attachment":[{"href":"https:\/\/opv.vn\/en\/wp-json\/wp\/v2\/media?parent=296"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/opv.vn\/en\/wp-json\/wp\/v2\/product_cat?post=296"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/opv.vn\/en\/wp-json\/wp\/v2\/product_tag?post=296"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}