Omnafos Sachets

OMNAFOS SACHETS by MACLEODS PHARMACEUTICALS LTD

Name

Brand Name: OMNAFOS SACHETS Common Name: Fosfomycin

Composition

OMNAFOS SACHETS contain Fosfomycin (as Fosfomycin Trometamol), typically in an 8 gm dosage per sachet. Fosfomycin is a broad-spectrum antibiotic that inhibits bacterial cell wall formation and reduces bacterial attachment to the urinary bladder lining.

Uses

OMNAFOS SACHETS are prescribed for the treatment and prevention of various bladder infections. They are used for uncomplicated urinary tract infections (UTIs) caused by susceptible bacteria and for managing cystitis (inflammation of the bladder). In some instances, it may also be used to prevent UTIs in high-risk patients or for post-surgical UTI prevention.

Dosage and Administration

The contents of one sachet should be dissolved in 3 to 4 ounces (about half a cup) of water and consumed immediately after dissolving. It should be taken on an empty stomach, either one hour before a meal or at least two hours after a meal, often before bedtime after emptying the urinary bladder. Do not chew, crush, or break the sachet contents, and do not use hot water.

Side Effects

Common Side Effects:

• Dizziness
• Headache
• Indigestion
• Vulvovaginitis (swelling or infection of the vulva and vagina)
• Nausea and vomiting
• Loose and watery stools or diarrhea

Serious Side Effects:

• Severe allergic reactions (skin rash, itching, swelling, severe dizziness, difficulty breathing)
• Severe diarrhea, which may be a sign of Clostridioides difficile-associated diarrhea, and can occur even months after stopping the medicine.

Precautions

Inform your doctor if you are allergic to any components of OMNAFOS SACHETS. Pregnant or breastfeeding individuals should consult their doctor before use. It is not recommended for children below 12 years of age. OMNAFOS SACHETS are contraindicated in patients with severe kidney disease or those undergoing hemodialysis. Exercise caution if you have liver disease. Avoid driving or operating machinery if you experience dizziness or tiredness. Metoclopramide may reduce the absorption of Fosfomycin, so co-administration should be discussed with a doctor. Do not stop taking the medicine without consulting your doctor. Maintain good hydration by drinking plenty of water and avoid alcohol, soda, coffee, tea, artificial sweeteners, spicy foods, and citrus fruits.

Storage

Store OMNAFOS SACHETS in a cool and dry place, away from direct sunlight, at a temperature between 10ºC to 25ºC or below 30ºC. Keep out of sight and reach of children.

What is OMNAFOS SACHETS used for?

OMNAFOS SACHETS are primarily used to treat or prevent bladder infections, also known as urinary tract infections (UTIs) or cystitis. It is effective against uncomplicated UTIs caused by susceptible bacteria and may also be prescribed for post-surgical UTI prevention.

How does OMNAFOS SACHETS work?

OMNAFOS SACHETS contain the active ingredient Fosfomycin, which is an antibiotic. It works by inhibiting the formation of the bacterial cell wall, a protective covering essential for bacterial survival, thereby killing the bacteria. Additionally, it helps prevent bacteria, such as E. coli, from attaching to the cells lining the urinary bladder, further preventing infection.

What is the usual dosage for OMNAFOS SACHETS?

For adults, the typical dosage is one packet (3 grams) of OMNAFOS SACHETS, dissolved in 3 to 4 ounces (about half a cup) of cold water, and taken as a single dose. It should be consumed immediately after dissolving. It is usually taken on an empty stomach, either one hour before a meal or at least two hours after a meal, preferably before bedtime and after emptying the urinary bladder. OMNAFOS SACHETS are generally not recommended for children under 12 years of age.

What are the possible side effects of OMNAFOS SACHETS?

Common side effects may include dizziness, headache, indigestion, nausea, loose and watery stools (diarrhea), and vulvovaginitis (swelling or infection of the vulva and vagina). Most of these side effects are usually temporary and resolve on their own. Less common but more serious side effects can include severe allergic reactions (e.g., skin rash, itching, swelling of the face/throat, difficulty breathing) or severe and persistent diarrhea, which could be a sign of a more serious condition. If you experience severe or persistent side effects, contact your doctor immediately.

Is OMNAFOS SACHETS safe during pregnancy or breastfeeding?

During Pregnancy: OMNAFOS SACHETS are generally not recommended during pregnancy unless your doctor determines that the potential benefits outweigh the risks. Limited human studies are available, so it's crucial to discuss your pregnancy status with your doctor before taking this medicine.

During Breastfeeding: Small amounts of fosfomycin are excreted in human milk. While some sources suggest it may be used with caution as infant absorption is unlikely, it is generally advised to avoid during breastfeeding unless specifically recommended by your doctor after a careful assessment of benefits versus risks.

Can OMNAFOS SACHETS be taken with other medications?

You should inform your doctor about all medications you are currently taking, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements. Taking OMNAFOS SACHETS with metoclopramide may reduce the absorption of fosfomycin. While specific food interactions are not widely reported, it is advisable to avoid alcohol and caffeinated drinks, as they can exacerbate urinary tract infection symptoms and potentially slow your immune response.

What precautions should be taken while using OMNAFOS SACHETS?

Inform your doctor if you have any allergies to the components of OMNAFOS SACHETS. It is contraindicated in patients with severe kidney disease or those undergoing hemodialysis. Use with caution if you have liver disease or a history of diarrhea caused by other antibiotics. Since the medicine can cause dizziness or tiredness, avoid driving or operating heavy machinery until you know how it affects you. It is important to complete the full prescribed course of antibiotics, even if your symptoms improve, to prevent the infection from worsening or recurring. Drinking plenty of water is recommended, and avoiding bladder irritants like spicy foods, citrus fruits, alcohol, soda, coffee, tea, and artificial sweeteners can also be beneficial.

What happens if a dose of OMNAFOS SACHETS is missed?

OMNAFOS SACHETS (Fosfomycin) is typically prescribed as a single-dose treatment. This single dose is usually considered the complete course of therapy. If you miss taking this single dose, contact your doctor immediately for guidance on when to take it.

How should OMNAFOS SACHETS be stored?

Store OMNAFOS SACHETS in a cool and dry place, away from direct sunlight. The recommended storage temperature is between 10°C and 25°C (50°F and 77°F), or below 30°C (86°F). Keep the medicine out of sight and reach of children.