Kofnix SR50 mg

Established Use — Dry (Non-Productive) Cough

Kofnix SR is indicated for the symptomatic relief of dry, irritating (non-productive) cough of various causes, including cough associated with the common cold, acute upper respiratory tract infections, and other conditions that cause an irritating cough without significant mucus or phlegm production. Kofnix SR works by suppressing the cough reflex; it does not treat the underlying cause of the cough.

Not for Productive (Chesty) Cough

Kofnix SR should not be used for a productive (chesty, mucus-producing) cough, where coughing is helping to clear secretions from the airways. Suppressing this type of cough with Kofnix SR can allow mucus to build up in the lungs and airways, which may worsen breathing difficulty or increase the risk of chest infection. For this reason, Kofnix SR should not be combined with mucolytic or expectorant medicines (see Interaction and Precautions and Warnings for the full explanation).

Guideline-Supported — Peri-Operative Use

Regulatory product information supports the use of Kofnix SR to suppress cough before and after surgical procedures, and during diagnostic procedures such as bronchoscopy, where coughing could interfere with the procedure itself or with post-operative recovery.

Adjunct / Off-Label Use

Some regional product literature for Kofnix SR also describes its adjunctive use for cough associated with whooping cough (pertussis) and acute inflammation of the lower respiratory tract. In these situations, Kofnix SR is used only as an adjunct to relieve the cough symptom, alongside appropriate antimicrobial and supportive treatment of the underlying infection, and its use should be guided by a physician.

Each formulation of Butamirate Citrate contains Butamirate Citrate as its active ingredient. In Bangladesh, Butamirate Citrate is marketed as: sustained-release tablets containing Butamirate Citrate 50 mg; oral syrup containing Butamirate Citrate 7.5 mg/5 mL; and pediatric oral drops containing Butamirate Citrate 5 mg/mL.

Kofnix SR is a non-opioid, centrally-acting cough-suppressant (antitussive) medicine used to relieve a dry, irritating cough that is not helping to clear mucus from the airways. Unlike opioid-based cough medicines, Kofnix SR is not derived from opium and does not typically cause the marked sedation or dependence associated with opioid antitussives, although mild drowsiness can occur. Kofnix SR is available in Bangladesh as tablets, syrup, and pediatric drops, allowing the dose to be tailored to adults, older children, and young children or infants under medical guidance. Kofnix SR is intended only for short-term, symptomatic relief of dry cough, and is not a treatment for productive (mucus-producing) cough or for the illness causing the cough. As with any medicine, Kofnix SR should be used strictly as directed by a doctor or pharmacist.

Antitussive (Cough Suppressant, Non-Opioid, Centrally-Acting)

Butamirate Citrate is thought to act mainly by reducing the sensitivity of the cough centre, thereby suppressing the cough reflex, without acting through opioid receptors; because it is not an opioid, Butamirate Citrate does not carry the respiratory-depressant or addictive potential associated with opioid cough suppressants. Product literature also describes mild peripheral effects of Butamirate Citrate on the airways, including anticholinergic and bronchodilating (bronchospasmolytic) activity, which may further ease breathing during a coughing episode. After oral intake, Butamirate Citrate is absorbed relatively quickly, is highly bound to plasma proteins, and is extensively broken down (hydrolysed) in the body to metabolites that are eliminated mainly via the kidneys.

• Tablets: Swallow the sustained-release Kofnix SR tablet whole with a glass of water; do not chew or crush it, as this can alter the sustained-release effect.
• Syrup: Measure each dose of Kofnix SR syrup using the measuring cup or spoon provided with the pack; wash and dry the measuring device after each use.
• Drops: Use the dropper supplied with the Kofnix SR pediatric drops to measure the exact number of drops or mL prescribed; the drops may be given directly or mixed into a small amount of water or liquid for infants and young children.
• Take Kofnix SR at evenly spaced intervals through the day, as directed on the label or by the prescriber.
• Do not exceed the dose or frequency of Kofnix SR prescribed by the doctor, and do not use it for longer than advised.
• If a dose of Kofnix SR is missed, take it as soon as remembered unless it is almost time for the next dose — in that case, skip the missed dose and do not double up.

• Mucolytics and expectorants (e.g., bromhexine, ambroxol, guaifenesin, acetylcysteine, carbocisteine): Kofnix SR should not be combined with mucolytic or expectorant medicines. Because Kofnix SR suppresses the cough reflex while mucolytics and expectorants work to loosen and increase respiratory secretions, using them together can allow mucus to accumulate in the airways instead of being cleared by coughing, increasing the risk of bronchospasm, breathing difficulty, and airway or chest infection.
• Centrally-acting/sedating medicines and alcohol: Because Kofnix SR can cause drowsiness in some patients, caution is advised when Kofnix SR is taken together with other sedating medicines or alcohol, as the drowsiness may be additive.
• Strong enzyme-inhibiting medicines or drugs with a narrow therapeutic index: Some product information for Kofnix SR advises caution when it is used together with medicines described as strong enzyme inhibitors or those with a narrow therapeutic index. A doctor or pharmacist should review all other medicines being taken before starting Kofnix SR.

Common Side Effects

Reported adverse effects of Kofnix SR include drowsiness, dizziness, nausea, diarrhoea, and itchy skin rash or urticaria. These are generally described as occurring in a small proportion of patients and often improve with dose reduction or discontinuation of Kofnix SR.

Serious Side Effects — Seek Medical Attention

Seek prompt medical attention if signs of a serious allergic reaction to Kofnix SR occur, such as swelling of the face, lips, tongue, or throat, severe skin rash, or difficulty breathing, or if severe dizziness, loss of balance, or a marked drop in blood pressure develops.

Pregnancy

Kofnix SR is contraindicated during the first trimester of pregnancy. In the second and third trimesters, Kofnix SR should be used only if a doctor considers it clearly necessary, after weighing the potential benefit against the risk, as safety data for this period remain limited.

Breastfeeding

Use of Kofnix SR during breastfeeding is not recommended, as there is insufficient data on its excretion into breast milk and its effect on the nursing infant; some product information specifically advises against its use while breastfeeding. A doctor should be consulted before using Kofnix SR during breastfeeding.

• Do not use for a productive (mucus-producing) cough: Kofnix SR suppresses the cough reflex and should not be used when a cough is productively clearing mucus from the airways, because doing so can cause mucus retention, worsening breathing difficulty, and a higher risk of chest infection; for the same reason, Kofnix SR should not be combined with mucolytic or expectorant medicines (see Interaction).
• Cough persisting beyond about a week: If a cough being treated with Kofnix SR lasts more than about 7 days in adults, or more than about 3 days in children, or is accompanied by fever, rash, persistent headache, or breathing difficulty, medical advice should be sought rather than continuing Kofnix SR without review.
• Drowsiness, driving, and operating machinery: Because Kofnix SR can cause drowsiness or dizziness in some patients, caution is advised when driving or operating machinery until it is known how Kofnix SR affects the individual.
• Sugar/excipient content of some formulations: Some Kofnix SR syrup formulations contain sorbitol, fructose, or colourants; patients with hereditary fructose intolerance or known sensitivity to these excipients should check the label and consult a doctor or pharmacist before use.
• Limited data in renal or hepatic impairment and in elderly patients: Specific safety data for Kofnix SR in these groups are limited, so it should be used with caution and under medical supervision.
• Use the age-appropriate formulation in children: Kofnix SR should be given to a child only in the formulation and dose appropriate for that child's age, confirmed by a doctor or pharmacist, since not every approved Kofnix SR product is licensed for use in young children.

Reported symptoms of Kofnix SR overdose include drowsiness, nausea, vomiting, diarrhoea, loss of balance or dizziness, and low blood pressure (hypotension). There is no specific antidote for Kofnix SR overdose. If an overdose of Kofnix SR is suspected, do not induce vomiting unless specifically directed to do so by a doctor or a poison control service, and seek emergency medical attention or contact a poison control centre immediately. Management of Kofnix SR overdose is supportive and should be carried out by medical professionals in a hospital setting.

Store Kofnix SR below 30°C in a cool, dry place, protected from light and moisture, and out of the reach and sight of children. Because storage conditions can vary slightly between different brands and formulations (tablet, syrup, drops) of Kofnix SR, always store according to the specific instructions printed on the product label and pack, and discard any unused syrup or drops after the period stated on the label once the pack has been opened.

Children: Age-appropriate formulations and doses of Kofnix SR exist — pediatric drops for infants from about 2 months to 3 years of age, and syrup for children from about 3 years upward — but the exact minimum age and dose depend on the specific approved product, and some Kofnix SR products are approved for adults and adolescents only. A doctor should confirm the correct formulation and dose of Kofnix SR for a child.

Elderly: Specific data on the use of Kofnix SR in elderly patients are limited; Kofnix SR should be used with caution and under medical supervision, with attention to drowsiness.

Renal impairment: Specific data on Kofnix SR in patients with renal impairment are limited; use with caution and under medical supervision.

Hepatic impairment: Specific data on Kofnix SR in patients with hepatic impairment are limited; use with caution and under medical supervision.

Other: Patients with hereditary fructose intolerance should check the excipients of the specific Kofnix SR syrup formulation, as some contain sorbitol or fructose.

Kofnix SR is intended for short-term, symptomatic treatment of dry cough, generally for the duration prescribed by a doctor, often up to about one week. If the cough being treated with Kofnix SR persists for more than about 7 days in adults, or more than about 3 days in children, or is accompanied by fever, rash, persistent headache, or difficulty breathing, medical advice should be sought rather than continuing Kofnix SR without review, as a prolonged, unexplained cough may indicate an underlying condition that needs separate evaluation.

Antitussive; Non-opioid cough suppressant; Centrally-acting cough-reflex inhibitor

Butamirate Citrate acts primarily by reducing the sensitivity of the cough centre, thereby suppressing the cough reflex, without acting through opioid receptors. It also exhibits mild peripheral anticholinergic and bronchodilating (bronchospasmolytic) activity on the airways, which can help ease breathing during a coughing episode.

Kofnix SR is available in pediatric-specific formulations in Bangladesh — oral drops (5 mg/mL) and syrup (7.5 mg/5 mL) — that allow dosing to be tailored to a child's age. Per regional product information, drops are typically used in infants from about 2 months to 3 years of age, and syrup in children from about 3 years upward, with the specific dose depending on age (see the Dosage table). However, not every approved Kofnix SR product is licensed for pediatric use in every country — some are approved for adults and adolescents 18 years and above only — so the age-appropriateness of a given Kofnix SR product should always be confirmed from its specific label or by a doctor or pharmacist before use in a child.