Tobihale Resp

TOBIHALE RESP by LUPIN LTD-RESPIRA ORIAN DIV

TOBIHALE RESP is an inhaled antibiotic medication manufactured by Lupin Ltd. It is formulated as Respules for nebulization.

• Name: TOBIHALE RESP (Respules).

• Composition: Each Respule contains Tobramycin 300mg. Tobramycin is an aminoglycoside antibiotic.

• Uses:

  • Primarily used to treat chronic lung infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis aged six years and older.
  • Works by interfering with bacterial protein synthesis, effectively killing the bacteria and reducing respiratory symptoms.
  • May also be used in the management of hospital-acquired pneumonia and other severe lower respiratory tract infections.

• Dosage and Administration:

  • Administered via nebulizer for inhalation. The solution should not be injected or swallowed.
  • Typical dosage involves two single containers per day for 28 days (one in the morning and one in the evening), followed by a 28-day break, then repeating the cycle. Doses should be approximately 12 hours apart, and not less than 6 hours apart.
  • The first dose should be taken under medical supervision due to the potential for bronchospasm.
  • If using other respiratory therapies, administer bronchodilator, respiratory physiotherapy, other inhaled medications, and then TOBIHALE RESP.

• Side Effects:

  • Common: Runny or stuffy nose, sneezing, voice alteration (hoarseness), discolouration of sputum, worsening of lung function tests, feeling unwell, muscle pain, sore throat, cough, rash, taste change.
  • Serious (less common): Bronchospasm (tightening of airways), hearing loss (ototoxicity), dizziness, unsteadiness, or ringing in the ears.

• Precautions:

  • Do not use if allergic to Tobramycin or other aminoglycoside antibiotics.
  • Use with caution during pregnancy and breastfeeding; consult a doctor.
  • Inform your doctor if you have hearing problems, kidney issues, unusual breathing difficulties, chest tightness, blood in sputum, muscle weakness, or Parkinson's disease.
  • Not recommended for children under six years of age.
  • Kidney function should be monitored regularly during treatment.
  • Complete the full prescribed course of treatment to prevent antibiotic resistance and recurrence of infection.

• Storage:

  • Store in a refrigerator at 2-8°C (36-46°F). Do not freeze.
  • If removed from refrigeration, it can be stored at room temperature (up to 25°C/77°F) for up to 28 days. Avoid intense light. A color change does not necessarily indicate a change in quality.

TOBIHALE RESP is an inhalation solution containing the antibiotic Tobramycin. It is used to manage chronic lung infections, particularly in patients with cystic fibrosis. Here are some frequently asked questions about TOBIHALE RESP:

What is TOBIHALE RESP used for?

TOBIHALE RESP is an antibiotic primarily used to treat and prevent chronic lung and chest infections, especially those caused by the bacterium Pseudomonas aeruginosa, in patients with cystic fibrosis. It may also be used in some cases of hospital-acquired pneumonia or severe lower respiratory tract infections.

How does TOBIHALE RESP work?

TOBIHALE RESP contains Tobramycin, which is an aminoglycoside antibiotic. It works by targeting bacteria and inhibiting their protein synthesis. This action disrupts the bacterial cell's vital functions, leading to the breakdown of its cell envelope and ultimately cell death, thereby fighting the infection in the airways.

What is the usual dosage for TOBIHALE RESP?

The typical dosage is 300mg (one ampule/respule) administered twice daily via a nebulizer. It is usually taken for 28 consecutive days, followed by a 28-day "off" period, after which the 28-day "on" and "off" cycle is resumed. Doses should be approximately 12 hours apart and should not be taken less than 6 hours apart.

What are the possible side effects of TOBIHALE RESP?

Common side effects can include sore throat, cough, rash, breathlessness, increased sputum production, changes in taste or voice (hoarseness), runny or stuffy nose, sneezing, and muscle pain. More serious, but less common, side effects may involve hearing loss (ototoxicity), ringing in the ears (tinnitus), dizziness, kidney injury (indicated by decreased urine or swelling), muscle weakness, and bronchospasm (tightening of the airways). If you experience serious side effects like sudden breathing difficulties or hearing changes, seek medical attention immediately.

Is TOBIHALE RESP safe during pregnancy or breastfeeding?

During Pregnancy: TOBIHALE RESP (Tobramycin) is generally considered unsafe during pregnancy as there is definite evidence of risk to the developing baby. Aminoglycosides can cause fetal harm. Your doctor may only prescribe it in life-threatening situations where the potential benefits outweigh the risks. During Breastfeeding: Human studies suggest that TOBIHALE RESP is safe to use while breastfeeding, as the drug does not appear to pass into breast milk in significant amounts that would be harmful to the baby. However, it's always advisable to consult your doctor to discuss individual risks and benefits.

Can TOBIHALE RESP be taken with other medications?

It is crucial not to mix TOBIHALE RESP with other inhalation medicines, such as dornase alfa, in the nebulizer. If you are receiving multiple respiratory therapies, it is typically recommended to follow this order: bronchodilator, respiratory physiotherapy, other inhaled medicinal products, and then TOBIHALE RESP. Use with caution with other medications known to cause kidney damage (nephrotoxic) or hearing damage (ototoxic), such as certain diuretics (e.g., furosemide), NSAIDs, cisplatin, or other aminoglycoside antibiotics. It can also aggravate muscle weakness if taken with neuromuscular blocking agents or in individuals with conditions like myasthenia gravis or Parkinson's disease.

What precautions should be taken while using TOBIHALE RESP?

TOBIHALE RESP is for inhalation only via a nebulizer; it should not be injected or swallowed. The first dose should be taken under medical supervision as it can sometimes cause wheezing or tightening of the airways (bronchospasm). Inform your doctor if you have pre-existing conditions like hearing problems, kidney disease, unusual difficulty breathing, chest tightness, blood in your sputum, muscle weakness, or Parkinson's disease. Your kidney function and hearing should be monitored regularly throughout treatment. It's important to complete the full course of treatment as prescribed by your doctor, even if you feel better, to prevent the infection from returning or developing antibiotic resistance. TOBIHALE RESP is not recommended for children under 6 years of age.

What happens if a dose of TOBIHALE RESP is missed?

If you miss a dose of TOBIHALE RESP, take it as soon as you remember. However, if your next scheduled dose is less than 6 hours away, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one.

How should TOBIHALE RESP be stored?

TOBIHALE RESP should be stored in a refrigerator at 2-8°C (36-46°F). If it is removed from refrigeration or a refrigerator is unavailable, it can be stored at room temperature (up to 25°C/77°F) for a maximum of 28 days. It should be protected from intense or direct light, and it should not be frozen.