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Hikma launches Doxycycline for Injection

Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, has launched Doxycycline for Injection, USP, 100mg, in the US, through its US affiliate, Hikma Pharmaceuticals USA Inc.

Doxycycline for Injection is an antibiotic indicated to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. It is used to treat various bacterial infections, including pneumonia and other respiratory tract infections.According to IQVIA, US sales of Doxycycline for Injection, USP, 100mg, were approximately $43 million in the 12 months ending April 2021.

Hikma is the third largest US supplier of generic injectable medicines by volume, with a growing portfolio of over 100 products. Today one in every six injectable generic medicines used in US hospitals is a Hikma product.

CONTRAINDICATIONS

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This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

WARNINGS & PRECAUTIONS

The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drugs but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including doxycycline for injection, USP, and may range in severity from mild diarrhea to fatal colitis.
difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use.
Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in patients receiving doxycycline.
Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including doxycycline. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline associated IH. Concomitant use of isotretinoin and doxycycline should be avoided because isotretinoin is also known to cause pseudotumor cerebri. Although IH typically resolves after discontinuation of treatment, the possibility for permanent visual loss exists.
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines.
The anti-anabolic action of the tetracyclines may cause an increase in BUN. Studies to date indicate that this does not occur with the use of doxycycline in patients with impaired renal function.
As with other antibacterial drugs, use of doxycycline may result in overgrowth of nonsusceptible organisms, including fungi.
Incision and drainage or other surgical procedures should be performed in conjunction with antibacterial therapy, when indicated.
Prescribing doxycycline in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
All infections due to group A beta-hemolytic streptococci should be treated for at least 10 days.
Patients taking doxycycline should be advised:
To avoid excessive sunlight or artificial ultraviolet light while receiving doxycycline and to discontinue therapy if phototoxicity (e.g., skin eruption, etc.) occurs. Sunscreen or sunblock should be considered.
That the use of doxycycline might increase the incidence of vaginal candidiasis.
Patients should be counseled that antibacterial drugs, including doxycycline should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When doxycycline is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.

Source: Hikma
Date: Jun 25, 2021


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