Hypharin

White to off-white translucent oral gel, sweet in taste.
Each gram contains: Miconazole, BP 20 mg; Ethanol (96%), BP 7.59 mg; In an aqueous gel base q.s.

Antifungal (imidazole derivative).
Pharmacology: Pharmacodynamics: Miconazole possesses in vitro antifungal activity against the common dermatophytes and yeasts as well as an antibacterial activity against certain gram-positive bacilli and cocci. Its activity is based on the inhibition of the ergosterol biosynthesis in fungi and the change in the composition of the lipid components in the membrane, resulting in fungal cell necrosis.
Mechanism of action: The primary mechanism of action is through inhibition of the CYP450 14α-lanosterol demethylase enzyme, which results in altered ergosterol production and impaired cell membrane composition and permeability, which in turn leads to cation, phosphate, and low molecular weight protein leakage.
In addition, miconazole inhibits fungal peroxidase and catalase while not affecting NADH oxidase activity, leading to increased production of reactive oxygen species (ROS). Increased intracellular ROS leads to downstream pleiotropic effects and eventual apoptosis.
Pharmacokinetics: Absorption: There is little absorption through skin or mucous membranes when miconazole nitrate is applied topically.
Distribution: Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6%).
Metabolism and Excretion: The small amount of miconazole that is absorbed is eliminated predominantly in faeces as both unchanged drug and metabolites.

Hypharin oral gel is a medicine which is used to treat fungal infections of the mouth, throat and gullet. The gel contains miconazole which works by destroying the fungus that is present.

This medicine is for use in adults and children aged 4 months and over.
Infections of the mouth and throat: Adults and Children over 2 years: 2.5 mL of gel applied four times a day after food.
Infants 4 months - 2 years: 1.25 mL (¹/₄ measuring spoon) of gel applied four times a day after food.
Each application should be divided into smaller portions. If the infant is 4-6 months old, and is premature or has slow development, check with the physician first before using the medicine. The gel should not be swallowed immediately, but kept in the mouth as long as possible. The treatment should be continued for at least a week after the symptoms have disappeared. For oral candidosis, dental prosthesis should be removed at night and brushed with gel. If symptoms persist, talk to the doctor.
Missed dose: Do not apply the missed dose of gel.
Apply the next dose of gel as usual and keep using it as prescribed by the doctor.
Do not use a double dose of gel to make up for a missed dose.

There is no evidence that this product can lead to overdose when used as labeled.
What to do when patient has taken more than the recommended dose: If patient uses more Hypharin oral gel than was prescribed or if someone else has taken any, talk to a doctor or go to the nearest hospital casualty department right away.
If there are any further questions on the use of this product, ask the doctor or pharmacist.

Do not use Hypharin oral gel in: Patients allergic to miconazole, any of the other ingredients of this medicine or to other similar antifungal medicines; Patients suffering from liver problems; Infants under 4 months of age or those with swallowing reflex not yet fully developed because of risk of choking.
Do not use this medicine if the previously mentioned applies. If unsure, talk to the doctor or pharmacist before using Hypharin oral gel.

Take special care with Hypharin oral gel. Hypharin oral gel is sticky. This ensures that it stays in the mouth for as long as possible. If giving the gel to a child or infant, make sure that the gel does not close off the child's or infant's throat as they could choke on it. The gel should be placed at the front of the mouth - never put it at the back of the throat. If the infant is being treated with Hypharin oral gel, and the mother is breast-feeding, do not apply the gel to the nipple in order to give the gel to the infant.
Blood tests: If patient is also taking medicines to thin the blood (anticoagulants, such as warfarin) or if patient is taking phenytoin (a medicine for epilepsy), the doctor may want to check the level of medicines in the body by testing the blood.
Taking other medicines: Please tell the doctor or pharmacist if patient is taking or has recently taken any other medicines. This includes medicines bought without a prescription or herbal medicines.
Driving and using machines: Hypharin oral gel is not likely to affect the patient being able to drive or use any tools or machines.

Tell the doctor before using Hypharin oral gel if patient is pregnant, thinks patient may be pregnant or might become pregnant.
Patient may still be able to use Hypharin oral gel if the doctor thinks it is needed. Talk to the doctor before using this medicine if patient is breastfeeding. Ask the doctor or pharmacist for advice before taking any medicine if patient is pregnant or breastfeeding.

Stop using Hypharin oral gel and tell the doctor straight away if patient notices the following. Patient may need medical treatment.
Sudden swelling of the face, lips, tongue or throat; difficulty swallowing; hives (also known as nettle rash or urticaria) and breathing difficulties (angioedema, anaphylactic reactions); severe irritation, reddening or blistering of the skin. These may be signs of severe allergic reaction.
Severe skin disorders with peeling and/or rashes with small pus-containing pimples (with a fever) or blistering of the skin, mouth, eyes and genitals (toxic epidermal necrolysis or Stevens-Johnson Syndrome).
Light headedness. generalized itch, wheezing or difficulty breathing.
If patient is taking medicines to thin the blood (anticoagulants), such warfarin: unexpected bleeding or bruising, nosebleeds, coughing up blood, blood in the urine, black tarry stools or coffee ground vomit.
Other side effects which may occur: Common (affects 1 to 10 users in 100): Dry mouth, feeling sick (nausea), being sick (vomiting), mouth discomfort, regurgitation, product tastes abnormal.
Uncommon (affects 1 to 10 users in 1,000): Loss or abnormal sense of taste.
The following side effects were also seen in a small number of patients: Choking, diarrhea, inflammation of the liver (hepatitis), sore mouth, tongue discoloration, rash with pus filled pimple/blisters (acute generalized exanthematous pustulosis).

What other medicine or food should be avoided while taking this medicine: Tell the doctor or pharmacist if the patient is taking any of the following medicines: Medicines to thin the blood (anticoagulants) such as warfarin; Medicines for HIV infection such as saquinavir, they are called "antiviral protease inhibitors".
Medicines used in the treatment of cancer such as busulfan, docetaxel and a group of medicines known as "vinca alkaloids".
Medicines that act on the heart and blood vessels called "calcium channel-blockers" such as dihydropyridines and verapamil.
Medicines that are usually given after an organ transplant called cyclosporin, tacrolimus or rapamycin. Another name for rapamycin is sirolimus.
Medicines for epilepsy called phenytoin or carbamazepine.
Alfentanil - for pain.
Medicines used for anxiety or to help patients sleep (tranquilizers), such as buspirone, alprazolam, or brotizolam.
Midazolam - to help patients relax or sleep when given into a vein.
Rifabutin - for tuberculosis.
Methylprednisolone - for inflammation (given by mouth or injection).
Ebastine - for allergy.
Reboxetine - for depression.
Sulphonylureas such as chlorpropamide and glibenclamide (medicines for diabetes taken by mouth).
Sildenafil - for erection problems.
Trimetrexate - for aa type of pneumonia.
Tell the doctor or dentist before taking, or if patient is already taking any of the previously mentioned. They may need to alter the treatment.

Store the gel in its original packaging.
Store at temperatures not exceeding 30°C.
Protect from light. Do not freeze.

Oropharyngeal Anti-Infectives

A01AB09 - miconazole ; Belongs to the class of local antiinfective and antiseptic preparations. Used in the treatment of diseases of the mouth.

Non-Rx