Gigadryl
Gigadryl Uses, Dosage, Side Effects, Food Interaction and all others data.
Guaifenesin possesses a storied history, having been originally formally approved by the US FDA in 1952 and continues to be one of very few - if not perhaps the only drug that is readily available and used as an expectorant . Since that time the agent has been a combination component of various prescription and non-prescription over-the-counter cough and cold products and is currently a widely available over-the-counter generic medication . Although it is principally believed that guaifenesin elicits an action to facilitate productive cough to manage chest congestion , it is not known whether the agent can reliably mitigate coughing.
Regardless, on March 1, 2007, the FDA received a petition asking the FDA to notify the public that some antitussives, expectorants, decongestants, antihistamines, and cough/cold combinations are not known to be safe and effective in children under the age of 6 years . After the negotiation between FDA and major manufacturers, a voluntary transition of labels for not using guaifenesin in children under the age of 4 years was endorsed by FDA in 2008 .
Furthermore, there has also been contemporary research to suggest that guaifenesin possesses and is capable of demonstrating anticonvulsant and muscle relaxant effects to some degree possibly by acting as an NMDA receptor antagonist .
Peppermint Oil helps to relieve both the painful abdominal spasm and uncomfortable bloating of IBS. It has a relaxant, antispasmodic effect especially on the muscles of the large bowel or colon and in bowel spasm, particularly large-bowel spasm. It is carminative, antibacterial, mucolytic. Peppermint Oil helps to treat unpleasant sensations of fullness and bloating and facilitates the passing of bowel gases, so relieving accompanying cramp like pain.
Peppermint oil induces a dose-related antispasmodic effects on the gastrointestinal smooth muscles . A meta-analysis study and additional clinical studies of patients with IBS demonstrated that the treatment with peppermint oil improves abdominal symptoms compared to the placebo group, resulting in reduced severity of abdominal pain, decreased abdominal distension, reduced stool frequency, and reduced flatulence . The use of enteric-coated peppermint oil was shown to be effective in reducing gastrointestinal symptoms of non-ulcer dyspepsia . In rats, peppermint oil promoted a time-dependent choleretic effect in increasing bile production and biliary output . In randomized controlled trials, topical application of peppermint oil was associated with a significant analgesic effect and a reduction in headache intensity compared to placebo . In a study of C57BL/6 mice, topical application of peppermint oil for 4 weeks was associated with a prominent hair growth effects; a significant increase in dermal thickness, follicle number, and follicle depth .
| Trade Name | Gigadryl |
| Generic | Promethazine HCL + guaifenesin + peppermint oil + ekstrak thymi dan excipient |
| Weight | 5mg, 50mg, 5ml |
| Type | Syrup |
| Therapeutic Class | |
| Manufacturer | Solas Langgeng Sejahtera |
| Available Country | Indonesia |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Guaifenesin is an expectorant commonly found in OTC products for the symptomatic relief from congested chests and coughs associated with cold, bronchitis, and/or other breathing illnesses.
Guaifenesin is an expectorant that is indicated for providing temporary symptomatic relief from congested chests and coughs which may be due to a cold, bronchitis, and/or other breathing illnesses .
Each enteric coated liquid filled hard gelatin capsule contains 187 mg (0.2 ml) of peppermint oil.
Peppermint Oil is used in Irritable bowel syndrome (IBS), Functional dyspepsia, Abdominal pain and spasm, Abdominal distension/bloating
Peppermint leaf preparations consist of the fresh or dried leaf of Mentha x piperita L. The whole dried leaf must contain not less than 1.2% (ml/gm) and the cut leaf must contain not less than 0.9% volatile oil. Peppermint oil consists of the essential oil, obtained by steam-distilling freshly harvested, flowering springs and is neither partially nor wholly dementholized.
Gigadryl is also used to associated treatment for these conditions: Allergic Reaction, Asthma, Asthma, Allergic, Bronchial Asthma, Bronchitis, Bronchospasm, Chronic Bronchitis, Chronic Obstructive Respiratory Diseases, Common Cold, Cough, Cough caused by Common Cold, Coughing caused by Allergies, Coughing caused by Flu caused by Influenza, Drug Allergy, Emphysema, Fever, Flu caused by Influenza, Food Allergy, Headache, House dust allergy, Irritative cough, Laryngitis, Nasal Congestion, Nasal Congestion caused by Common Cold, Phlegm, Pollen Allergy, Productive cough, Rash, Rhinorrhoea, Sneezing, Sore Throat, Tracheitis, Urticaria, Whooping Cough, Acute Rhinitis, Chest congestion, Chills occurring with fever, Dry cough, Excess mucus or phlegm, Mild to moderate pain, Minor aches and pains, Airway secretion clearance therapy, ExpectorantColic, Cough, Flatulence, Hypertonicity of the small intestine, Irritable Bowel Syndrome (IBS), Mild pain, Nasal Congestion, Soreness, Muscle, Gas pain
How Gigadryl works
Although the exact mechanism of action of guaifenesin may not yet be formally or totally elucidated, it is believed that expectorants like guaifenesin function by increasing mucus secretion . Moreover, it is also further proposed that such expectorants may also act as an irritant to gastric vagal receptors, and recruit efferent parasympathetic reflexes that can elicit glandular exocytosis that is comprised of a less viscous mucus mixture . Subsequently, these actions may provoke coughing that can ultimately flush difficult to access, congealed mucopurulent material from obstructed small airways to facilitate a temporary improvement for the individual .
Consequently, while it is generally proposed that guaifenesin functions as an expectorant by helping to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive, there has also been research to suggest that guaifenesin possesses and is capable of demonstrating anticonvulsant and muscle relaxant effects to some degree possibly by acting as an NMDA receptor antagonist .
Dose-dependent antispasmodic effect of peppermint oil is largely mediated by its menthol constituent . It is proposed that peppermint oil relaxes gastrointestinal smooth muscle and attenuates contractile responses by reducing the influx of extracellular calcium ions. In rabbit jejunum smooth muscle cells investigated via whole cell clamp configuration technique, peppermint oil was shown to inhibit the potential-dependent calcium currents in a concentration-dependent manner . Both a reduction in peak current amplitude and an increase in the rate of current decay were observed, indicating that the pharmacological activity peppermint oil resembles that of dihydropyridine calcium antagonists . In a rat small intestine study, peppermint oil in the intestinal lumen inhibited enterocyte glucose uptake via a direct action on the brush border membrane and inhibited intestinal secretion . There is also evidence that menthol is an antagonist of L-type Ca2+ channels via interacting with dihydropyridine binding sites and blocks the currents of low-voltage-activated calcium channels . Peppermint oil may facilitate hair growth by promoting the conservation of vascularization of hair dermal papilla, which may contribute to the induction of early anagen stage of active growth phase of hair follicles .
Dosage
Gigadryl dosage
Adults: 1 capsule 3 times daily with a glass of water. The dose may be increased to a maximum of 2 capsules 3 times daily or as directed by a physician.
Children (8 years and above): 1 capsule 3 times daily with a glass of water or a directed by a physician.
Toxicity
The most prevalent signs and symptoms associated with an overdose of guaifenesin have been nausea and vomiting .
Although adequate and well-controlled studies in pregnant women have not been performed, the Collaborative Perinatal Project monitored 197 mother-child pairs exposed to guaifenesin during the first trimester . An increased occurrence of inguinal hernias was found in the neonates . However, congenital defects were not strongly associated with guaifenesin use during pregnancy in 2 large groups of mother-child pairs .
Moreover, guaifenesin is excreted in breast milk in small quantities . Subsequently, caution should be exercised by balancing the potential benefit of treatment against any possible risks .
Additionally, an LD50 value of 1510 mg/kg (rat, oral) has been reported for guaifenesin .
Oral LD50 value in rat is 2426 mg/kg . In fasted mice, the LD50 following oral administration was 2410 mg/kg . Higher doses of peppermint oil has the potential to induce menstruation, bronchospasm, tongue spasms, and, possibly, respiratory arrest in addition to potential hepatotoxicity and nephrotoxicity .
Overdose may cause severe gastrointestinal symptoms, diarrhoea, rectal ulceration, epileptic convulsions, loss of consciousness, apnoea, nausea, disturbances in cardiac rhythms, ataxia and other CNS problems, probably due to the presence of menthol . In the event of overdose, the stomach should be emptied by gastric lavage. Observation should be carried out with symptomatic treatment if necessary . A near fatal case of high dose peppermint oil ingestion was reported, the overdose was characterized by comatose and reduced heart rate .
Precaution
Should not be taken with food or immediately after meals. Should be taken 30 to 60 minutes before meals. Must be swallowed whole, with a little liquid. Capsules must not be chewed or crushed.
Interaction
Exacerbation of adverse effects if taken with alcohol; enteric-coated preparations containing peppermint oil should not be taken immediately with antacids.
Volume of Distribution
The geometric mean apparent volume of distribution of guaifenesin determined in healthy adult subjects is 116L (CV=45.7%) .
No pharmacokinetic data available.
Elimination Route
Studies have shown that guaifenesin is well absorbed from and along the gastrointestinal tract after oral administration .
After oral administration, peppermint is rapidly absorbed . Menthol is highly fat-soluble therefore rapidly absorbed from the proximal gut .
Half Life
The half-life in plasma observed for guaifenesin is approximately one hour .
No pharmacokinetic data available.
Clearance
The mean clearance recorded for guaifenesin is about 94.8 L/hr (CV=51.4%) .
No pharmacokinetic data available.
Elimination Route
After administration, guaifenesin is metabolized and then largely excreted in the urine .
Peppermint oil is eliminated mainly via the bile following oral administration, with glucuronide and sulphate metabolites predominant . The metabolites, mainly menthol glucuronide and mono- or di-hydroxylated menthol derivatives, may also undergo approximately equal renal and fecal excretion . Renal recovery of total menthol within 24 hours was dose-dependent whereas the recovery in bile was substantially higher over 8 hours .
Pregnancy & Breastfeeding use
No known restrictions.
Contraindication
Contraindicated in patients with achlorhydria. Also contraindicated for infants due to the potential risk of spasm of the tongue or respiratory arrest.
Storage Condition
Keep in a cool & dry place, away from direct sunlight. Keep out of reach of children.
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