Otina

Betamethasone (Otina) Suspension is indicated for the treatment of acute and chronic corticosteroid-responsive disorders. Corticosteroid hormone therapy is an adjunct to, and not a replacement for conventional therapy.

Musculoskeletal and Soft Tissue Conditions: Rheumatoid arthritis, osteoarthritis, bursitis, ankylosing spondylitis, epicondylitis, radiculitis, coccydynia, sciatica, lumbago, torticollis, ganglion cyst, exostasis and fasciitis.

Allergic Conditions: Chronic bronchial asthma (including adjunctive therapy for status asthmaticus), hay fever, angioneurotic edema, allergic bronchitis, seasonal or perennial allergic rhinitis, drug reactions, serum sickness and insect bites.

Dermatologic Conditions: Atopic dermatitis (nummular eczema), neurodermatitis (circumscribed lichen simplex), contact dermatitis, severe solar dermatitis, urticaria, hypertrophic lichen planus, necrobiosis lipoidica diabeticorum, alopecia areata, discoid lupus erythematosus, psoriasis, keloids, pemphigus, dermatitis herpetiformis and cystic acne.

Collagen Diseases: Disseminated lupus erythematosus, scleroderma, dermatomyositis, periarteritis nodosa.

Neoplastic Diseases: Palliative management of leukemias and lymphomas in adults; acute leukemia of childhood.

Other Conditions: Adrenogenital syndrome, ulcerative colitis, regional ileitis, sprue, podiatric conditions (bursitis under heloma durum, hallux rigidus, digiti quinti varus), affections requiring subconjunctival injection, corticosteroid-responsive blood dyscrasias, nephritis and nephrotic syndrome.

Primary or secondary adrenocortical insufficiency may be treated with Betamethasone (Otina) Suspension but should be supplemented with mineralocorticosteroids, if applicable.

Betamethasone (Otina) Suspension is recommended for intramuscular injection in conditions responsive to systemic corticosteroids; injection directly into the affected soft tissues where indicated; intra-articular and periarticular injection in arthritides; intralesional injection in various dermatologic conditions; and local injection in certain inflammatory and cystic disorders of the foot.

In accord with the concepts in the Warning Box and this INDICATIONS AND USAGE section, chloramphenicolmust be used only in those serious infections for which less potentially dangerous drugs are ineffective or contraindicated. However, Chloramphenicol (Otina) may be chosen to initiate antibiotic therapy on the clinical impression that one of the conditions below is believed to be present; in vitro sensitivity tests should be performed concurrently so that the drug may be discontinued as soon as possible if less potentially dangerous agents are indicated by such tests. The decision to continue use of Chloramphenicol (Otina) rather than another antibiotic when both are suggested by in vitro studies to be effective against a specific pathogen should be based upon severity of the infection, susceptibility of the pathogen to the various antimicrobial drugs, efficacy of the various drugs in the infection, and the important additional concepts contained in the Warning Box above.

1. Acute infections caused by Salmonella typhi*

It is not recommended for the routine treatment of the typhoid carrier state.

2. Serious infections caused by susceptible strains in accordance with the concepts expressed above:

a) Salmonella species

b) H. influenzae, specially meningeal infections

c) Rickettsia

d) Lymphogranuloma-psittacosis group

e) Various gram-negative bacteria causing bacteremia, meningitis, or other serious gram-negative infections

f) Other susceptible organisms which have been demonstrated to be resistant to all other appropriate antimicrobial agents.

3. Cystic fibrosis regimens

*In treatment of typhoid fever some authorities recommend that Chloramphenicol (Otina) be administered at therapeutic levels for 8 to 10 days after the patient has become afebrile to lessen the possibility of relapse.

Epidural

Epidural anaesthesia

Adult: 2-3 mL administered for each dermatome to be anaesthesised. Recommended doses are: Lumbar epidural 250-300 mg (as 1% soln) for analgesia and 225-300 mg (as 1.5% soln) or 200-300 mg (as 2% soln) for anaesth; for thoracic epidural: 200-300 mg (as 1% soln). For obstetric caudal analgesia, 200-300 mg (as 1% soln); for surgical caudal anaesth: 225-300 mg (as 1.5% soln). For continuous epidural or caudal anaesth, not to repeat max doses more frequently than 1.5 hrly.

Intramuscular

Emergency treatment of ventricular arrhythmias

Adult: 300 mg injected into the deltoid muscle, repeat after 60-90 min if necessary.

Intraspinal

Spinal anaesthesia

Adult: As hyperbaric soln of 1.5% or 5% Lidocaine (Otina) in 7.5% glucose soln. Normal vaginal delivery: Up to 50 mg (as 5% soln) or 9-15 mg (as 1.5% soln). Caesarian operation: Up to 75 mg (as 5% soln). Other surgical procedures: 75-100 mg.

Intravenous

Pulseless ventricular fibrillation or ventricular tachycardia

Adult: 1-1.5 mg/kg repeated as necessary. Max: 3 mg/kg. For ventricular arrhythmias in more stable patients: Usual loading dose: 50-100 mg as an IV inj at 25-50 mg/min, may repeat once or twice up to a max of 200-300 mg in 1 hr, followed by 1-4 mg/min via continuous IV infusion. May need to reduce dose if the infusion is longer than 24 hr.

Intravenous

Intravenous regional anaesthesia

Adult: As 0.5% soln w/o epinephrine: 50-300 mg. Max: 4 mg/kg.

Mouth/Throat

Surface anaesthesia

Adult: As 2% soln: For pain: 300 mg rinsed and ejected for mouth and throat pain; or gargled and swallowed if necessary for pharyngeal pain. Not to be used more frequently than every 3 hr. Max (topical oral soln): 2.4 g/day. As 4% soln: Before bronchoscopy, bronchography, laryngoscopy, oesophagoscopy, endotracheal intubation, and biopsy in the mouth and throat: 40-200 mg. As 10% soln: For dentistry and otorhinolaryngology procedures: 10-50 mg sprayed to mucous membrane. As 4% soln: For laryngotracheal anaesth: 160 mg sprayed or instilled as a single dose into the lumen of the larynx and trachea.

Ophthalmic

Surface anaesthesia

Adult: Apply 2 drops to ocular area where procedure will take place; may reapply to maintain effect.

Parenteral

Percutaneous infiltration anaesthesia

Adult: As 0.5% or 1% soln: 5-300 mg.

Parenteral

Sympathetic nerve block

Adult: As 1% soln: 50 mg for cervical block or 50-100 mg for lumbar block.

Parenteral

Peripheral nerve block

Adult: As 1.5% soln: For brachial plexus block: 225-300 mg. As 2% soln: For dental nerve block: 20-100 mg. As 1% soln: For intercostal nerve block: 30 mg; for paracervical block: 100 mg on each side, repeated not more frequently than every 90 min; for paravertebral block: 30-50 mg; for pudendal block: 100 mg on each side. As 4% soln: For retrobulbar block: 120-200 mg.

Rectal

Haemorrhoids, Perianal pain and itching

Adult: Apply topically or using applicator insert rectally, up to 6 times daily.

Child: ≥12 yr Apply topically or using applicator insert rectally, up to 6 times daily.

Topical/Cutaneous

Surface anaesthesia

Adult: As 5% oint: Max: 20 g in 24 hr for skin and mucous membrane. As 2% gel: Approx 120-220 mg into urethra several min before examination. As 4% foam: Apply 3-4 times daily for pain relief. As soln: Apply 40-200 mg to affected area. As patch: Apply patch to painful area for up to 12 hr w/in a 24-hr period. Max: 1 patch/24 hr.

Transdermal

Postherpetic neuralgia

Adult: As 5% patch: Apply to most painful area once daily for up to 12 hr w/in a 24-hr period. Max: Up to 3 patches in a single application.

Urethral

Surface anaesthesia

Adult: As 2% gel: Female: 60-100 mg inserted into the urethra several min before examination. Male: 100-200 mg before catheterisation and 600 mg before sounding or cystoscopy.

Betamethasone (Otina) sodium phosphate and Betamethasone (Otina) acetate combination injection provides relief for inflamed areas of the body. It is used to treat a number of different conditions, such as inflammation (swelling), severe allergies, adrenal problems, arthritis, lung or breathing problems, blood or bone marrow problems, eye or vision problems, lupus, serious skin conditions, kidney problems, ulcerative colitis, and flare-ups of multiple sclerosis. Betamethasone (Otina) sodium phosphate and Betamethasone (Otina) acetate combination is a corticosteroid (cortisone-like medicine or steroid). It works on the immune system to help relieve swelling, redness, itching, and allergic reactions.

Betamethasone (Otina) sodium phosphate and Betamethasone (Otina) acetate is to be given only by or under the direct supervision of your doctor.

Chloramphenicol (Otina) belongs to the family of medicines called antibiotics. Chloramphenicol (Otina) ophthalmic preparations are used to treat infections of the eye. Chloramphenicol (Otina) may be given alone or with other medicines that are taken by mouth for eye infections.

Chloramphenicol (Otina) is available only with your doctor's prescription.

Lidocaine (Otina) topical jelly or ointment is used on different parts of the body to cause numbness or loss of feeling for patients having certain medical procedures. It is also used to relieve pain and itching caused by conditions such as sunburn or other minor burns, insect bites or stings, poison ivy, poison oak, poison sumac, minor cuts, or scratches.

Lidocaine (Otina) viscous topical solution is also used to treat sore mouth or throat and also reduce gagging during the taking of X-ray pictures and dental impressions.

Lidocaine (Otina) skin patch is used to relieve pain caused by shingles (postherpetic neuralgia).

Lidocaine (Otina) belongs to the family of medicines called local anesthetics. Lidocaine (Otina) prevents pain by blocking the signals at the nerve endings in the skin. Lidocaine (Otina) does not cause unconsciousness as general anesthetics do when used for surgery.

Lidocaine (Otina) is available only with your doctor's prescription.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Kit, Injection:

Pod-Care 100C: Betamethasone (Otina) sodium phosphate 3 mg and Betamethasone (Otina) acetate 3 mg per 1 mL [contains benzalkonium chloride, disodium edta]

ReadySharp Betamethasone (Otina): Betamethasone (Otina) sodium phosphate 3 mg and Betamethasone (Otina) acetate 3 mg per 1 mL [contains benzalkonium chloride, disodium edta]

Suspension, Injection:

Betamethasone (Otina): Betamethasone (Otina) sodium phosphate 3 mg and Betamethasone (Otina) acetate 3 mg per 1 mL (5 mL) [contains benzalkonium chloride, edetate disodium]

Generic: Betamethasone (Otina) sodium phosphate 3 mg and Betamethasone (Otina) acetate 3 mg per 1 mL (5 mL)

Dosing: Adult

Note: Dosages expressed as combined amount of Betamethasone (Otina) sodium phosphate and Betamethasone (Otina) acetate; 1 mg is equivalent to Betamethasone (Otina) sodium phosphate 0.5 mg and Betamethasone (Otina) acetate 0.5 mg.

Usual dosage range: IM: Initial: 0.25 to 9 mg/day (based on severity of disease and patient response).

Indication-specific dosing:

Antenatal fetal maturation (off-label use): IM: 12 mg every 24 hours for a total of 2 doses (ACOG 171 2016). A single course of Betamethasone (Otina) is recommended for women between 24 and 34 weeks of gestation, including those with ruptured membranes or multiple gestations, who are at risk of delivering within 7 days. A single course may be appropriate in some women beginning at 23 weeks gestation or late preterm (between 34 0/7 weeks and 36 6/7 weeks gestation). A single repeat course may be considered in some women with pregnancies less than 34 weeks gestation at risk for delivery within 7 days and who had a course of antenatal corticosteroids >14 days prior (ACOG 171 2016; ACOG 713 2017, ACOG 188 2018).

Bursitis (other than of foot): Intra-articular: 3 to 6 mg (0.5 to 1 mL) for one dose; additional injections may be required for acute exacerbations or chronic conditions; generally, injections should be separated by a minimum of 4 to 6 weeks and limited to ≤4 injections per year. If symptoms are not improved after 1 or 2 injections, additional injections are unlikely to provide benefit (Cardone 2002); following resolution of acute episodes, reduced doses may be warranted for chronic conditions.

Dermatologic conditions: Intradermal: 1.2 mg/cm displayed a good or excellent response (Chowdri, 1994). Another trial (n=25, age range: 7 weeks to 2 years) used lower doses of 3 to 12 mg (in combination with triamcinolone); 16 patients experienced a marked response (Kushner, 1985).

Chloramphenicol (Otina), like other potent drugs, should be prescribed at recommended doses known to have therapeutic activity. Administration of 50 mg/kg/day in divided doses will produce blood levels of the magnitude to which the majority of susceptible microorganisms will respond.

As soon as feasible an oral dosage form of another appropriate antibiotic should be substituted for intravenous Chloramphenicol (Otina) sodium succinate.

The following method of administration is recommended:

Intravenously as a 10% (100 mg/mL) solution to be injected over at least a one-minute interval. This is prepared by the addition of 10 mL of an aqueous diluent such as water for injection or 5% dextrose injection.

Adults

Adults should receive 50 mg/kg/day in divided doses at 6-hour intervals. In exceptional cases patients with infections due to moderately resistant organisms may require increased dosage up to 100 mg/kg/day to achieve blood levels inhibiting the pathogen, but these high doses should be decreased as soon as possible. Adults with impairment of hepatic or renal function or both may have reduced ability to metabolize and excrete the drug. In instances of impaired metabolic processes, dosages should be adjusted accordingly. Precise control of concentration of the drug in the blood should be carefully followed in patients with impaired metabolic processes by the available microtechniques (information available on request).

Pediatric Patients

Dosage of 50 mg/kg/day divided into 4 doses at 6-hour intervals yields blood levels in the range effective against most susceptible organisms. Severe infections (eg, bacteremia or meningitis), especially when adequate cerebrospinal fluid concentrations are desired, may require dosage up to 100 mg/kg/day; however, it is recommended that dosage be reduced to 50 mg/kg/day as soon as possible. Children with impaired liver or kidney function may retain excessive amounts of the drug.

Neonates

A total of 25 mg/kg/day in 4 equal doses at 6-hour intervals usually produces and maintains concentrations in blood and tissues adequate to control most infections for which the drug is indicated. Increased dosage in these individuals, demanded by severe infections, should be given only to maintain the blood concentration within a therapeutically effective range. After the first two weeks of life, full-term neonates ordinarily may receive up to a total of 50 mg/kg/day equally divided into 4 doses at 6-hour intervals. These dosage recommendations are extremely important because blood concentration in all premature and full-term neonates under two weeks of age differs from that of other infants neonates. This difference is due to variations in the maturity of the metabolic functions of the liver and the kidneys.

When these functions are immature (or seriously impaired in adults), high concentrations of the drug are found which tend to increase with succeeding doses.

Pediatric Patients with Immature Metabolic Processes

In young infants and other pediatric patients in whom immature metabolic functions are suspected, a dose of 25 mg/kg/day will usually produce therapeutic concentrations of the drug in the blood. In this group particularly, the concentration of the drug in the blood should be carefully followed by microtechniques. (Information available on request.)

When Lidocaine (Otina) USP, 5% is used concomitantly with other products containing Lidocaine (Otina), the total dose contributed by all formulations must be kept in mind.

Adult

A single application should not exceed 5 g of Lidocaine (Otina) USP, 5% containing 250 mg of Lidocaine (Otina) base (equivalent chemically to approximately 300 mg of Lidocaine (Otina) hydrochloride). This is roughly equivalent to squeezing a six (6) inch length of ointment from the tube. In a 70 kg adult this dose equals 3.6 mg/kg (1.6 mg/lb) Lidocaine (Otina) base. No more than 17-20 g of ointment or 850-1000 mg Lidocaine (Otina) base should be administered in any one day.

Although the incidence of adverse effects with Lidocaine (Otina) USP, 5% is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.

Dosage for children

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children less than ten years who have a normal lean body mass and a normal lean body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark's rule). For example, in a child of five years weighing 50 lbs., the dose of Lidocaine (Otina) should not exceed 75-100 mg when calculated according to Clark's rule. In any case, the maximum amount of Lidocaine (Otina) administered should not exceed 4.5 mg/kg (2.0 mg/lb) of body weight.

Administration

For medical use, apply topically for adequate control of symptoms. The use of a sterile gauze pad is suggested for application to broken skin tissue. Apply to the tube prior to intubation.

In dentistry, apply to previously dried oral mucosa. Subsequent removal of excess saliva with cotton rolls or saliva ejector minimizes dilution of the ointment, permits maximum penetration, and minimizes the possibility of swallowing the topical ointment.

For use in connection with the insertion of new dentures, apply to all denture surfaces contacting mucosa.

IMPORTANT: Patients should consult a dentist at intervals not exceeding 48 hours throughout the fitting period.

See also:
What is the most important information I should know about Betamethasone (Otina)?

You should not use this medication if you are allergic to Betamethasone (Otina), or if you have a fungal infection anywhere in your body.

Before taking Betamethasone (Otina), tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.

Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.

Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a "live" vaccine while you are taking Betamethasone (Otina). Vaccines may not work as well while you are taking a steroid.

Do not stop using Betamethasone (Otina) suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency.

See also:
What is the most important information I should know about Chloramphenicol (Otina)?

Chloramphenicol (Otina) Lotion is contraindicated for premature neonates because their skin may be more permeable than full term infants and their liver enzymes may not be sufficiently developed. It is also contraindicated for patients with Norwegian (crusted) scabies due to possible increased absorption. It is also contraindicated for patients with known seizure disorders and for individuals with a known sensitivity to the product or any of its components.

See also:
What is the most important information I should know about Lidocaine (Otina)?

You should not receive this medication if you are allergic to Lidocaine (Otina) or any other type of numbing medicine.

Before you receive Lidocaine (Otina) injection, tell your doctor if you have liver or kidney disease, heart disease, coronary artery disease, circulation problems, or a history of malignant hyperthermia.

To treat irregular heart rhythms, your doctor may prescribe a LidoPen auto-injector. This is a prefilled automatic injection device to be used in an emergency. Keep the device with you at all times.

Your doctor will describe the signs and symptoms to watch for when deciding when it's time to use Lidocaine (Otina) injection at home. Never use the LidoPen auto-injector without first calling your doctor.

With the LidoPen auto-injector you will also receive a CardioBeeper to transmit your heart rate and rhythm to your doctor over a telephone. Read all provided instructions and practice using the CardioBeeper.

Lidocaine (Otina) can cause side effects that may impair your thinking or reactions. Unless absolutely necessary, do not drive after using this medication

Use Betamethasone (Otina) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Betamethasone (Otina) by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Use the dropper that comes with Betamethasone (Otina) to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If Betamethasone (Otina) needs to be stopped (or if a different medicine is added to therapy) by your doctor, this will be done gradually. The risk of side effects may be increased if Betamethasone (Otina) is suddenly stopped.
• If you miss a dose of Betamethasone (Otina), take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Betamethasone (Otina).

Use Chloramphenicol (Otina) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Chloramphenicol (Otina) is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Chloramphenicol (Otina) at home, carefully follow the injection procedures taught to you by your health care provider.
• If Chloramphenicol (Otina) contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• To clear up your infection completely, continue using Chloramphenicol (Otina) for the full course of treatment even if you feel better in a few days.
• Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Chloramphenicol (Otina), use it as soon as possible. Then use your doses at evenly spaced times as directed by your doctor. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Chloramphenicol (Otina).

Use Lidocaine (Otina) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wash your hands well before and after using Lidocaine (Otina).
• Shake well before each use.
• If you are using Lidocaine (Otina) on your face, spray it into your hand. Gently apply. Do not spray Lidocaine (Otina) directly onto your face.
• For other areas, hold the medicine 4 to 6 inches from the skin and spray onto the affected area. Allow the medicine to slowly dry.
• Do not use large amounts of Lidocaine (Otina), especially over blistered or raw areas of your skin.
• Do not bandage or wrap the affected area, unless directed otherwise by your doctor.
• If you miss a dose of Lidocaine (Otina), use it as soon as you remember. Continue to use it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Lidocaine (Otina).

This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Betamethasone (Otina) reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a medium-strength corticosteroid.

How to use Betamethasone (Otina) topical

Use this medication on the skin only. However, do not use it on the face, groin, or underarms unless directed to do so by your doctor.

Wash and dry your hands before using. Clean and dry the affected area. Apply a thin film of medication to the affected area and gently rub in, usually 1-3 times daily or as directed by your doctor. Do not bandage, cover, or wrap the area unless directed to do so by your doctor. If used in the diaper area on an infant, do not use tight-fitting diapers or plastic pants.

After applying the medication, wash your hands unless you are using this medication to treat the hands. When applying this medication near the eyes, avoid getting it in the eyes because this may worsen or cause glaucoma. Also, avoid getting this medication in the nose or mouth. If you get the medication in these areas, rinse with plenty of water.

Use this medication only for the condition for which it was prescribed. Do not use it for longer than prescribed.

Inform your doctor if your condition persists or worsens after 2 weeks.

Use: Labeled Indications

Serious infections: Treatment of serious infections, including cystic fibrosis exacerbations, bacterial meningitis, and bacteremia, caused by Chlamydiaceae, Haemophilus influenzae, Rickettsia, Salmonella spp. (acute infections), and other organisms when other less toxic agents are ineffective or contraindicated.

Guideline recommendations: Chloramphenicol (Otina) may be considered for use as an alternative agent to doxycycline in the treatment of tickborne rickettsial diseases (eg, Rocky Mountain spotted fever [RMSF]); however, epidemiologic studies suggest that Chloramphenicol (Otina)-treated patients with RMSF are at a higher risk of death compared to tetracycline-treated patients. In addition, Chloramphenicol (Otina) is not effective in the treatment of human ehrlichiosis or anaplasmosis, therefore, use with caution in the empiric treatment of tickborne rickettsial diseases (CDC [Biggs 2016]).

How to use Lidocaine (Otina) topical

See also:
What other drugs will affect Betamethasone (Otina)?

There are no known drug interactions with topical Betamethasone (Otina) dipropionate.

Alcohol (Ethyl): Chloramphenicol (Otina) (Systemic) may enhance the adverse/toxic effect of Alcohol (Ethyl). Monitor therapy

Barbiturates: Chloramphenicol (Otina) (Systemic) may decrease the metabolism of Barbiturates. Barbiturates may increase the metabolism of Chloramphenicol (Otina) (Systemic). Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Carbocisteine: Chloramphenicol (Otina) (Systemic) may enhance the adverse/toxic effect of Carbocisteine. Specifically, Chloramphenicol (Otina) may enhance adverse effects of alcohol that is present in liquid formulations of carbocisteine-containing products. Monitor therapy

CefTAZidime: Chloramphenicol (Otina) (Systemic) may diminish the therapeutic effect of CefTAZidime. Management: Consider using a different combination of antimicrobials, especially if bactericidal activity is desired. If these agents are combined, monitor for reduced antimicrobial effectiveness and/or therapeutic failure. Consider therapy modification

Chloramphenicol (Otina) (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Avoid combination

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Avoid combination

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Monitor therapy

CycloSPORINE (Systemic): Chloramphenicol (Otina) (Systemic) may increase the serum concentration of CycloSPORINE (Systemic). Management: Cyclosporine dose reductions will likely be required with initiation of concurrent Chloramphenicol (Otina). Monitor cyclosporine concentrations and response closely following initiation and/or discontinuation of Chloramphenicol (Otina). Consider therapy modification

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Consider therapy modification

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Avoid combination

Fosphenytoin: May decrease the serum concentration of Chloramphenicol (Otina) (Systemic). Fosphenytoin may increase the serum concentration of Chloramphenicol (Otina) (Systemic). Chloramphenicol (Otina) (Systemic) may increase the serum concentration of Fosphenytoin. Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Mesalamine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy

Phenytoin: May decrease the serum concentration of Chloramphenicol (Otina) (Systemic). Phenytoin may increase the serum concentration of Chloramphenicol (Otina) (Systemic). Chloramphenicol (Otina) (Systemic) may increase the serum concentration of Phenytoin. Monitor therapy

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy

RifAMPin: May increase the metabolism of Chloramphenicol (Otina) (Systemic). Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Sulfonylureas: Chloramphenicol (Otina) (Systemic) may decrease the metabolism of Sulfonylureas. Monitor therapy

Tacrolimus (Systemic): Chloramphenicol (Otina) (Systemic) may increase the serum concentration of Tacrolimus (Systemic). Management: Tacrolimus dose reductions will likely be required with initiation of concurrent Chloramphenicol (Otina). Monitor tacrolimus concentrations and response closely following initiation and/or discontinuation of Chloramphenicol (Otina). Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

Vitamin B12: Chloramphenicol (Otina) (Systemic) may diminish the therapeutic effect of Vitamin B12. Monitor therapy

Vitamin K Antagonists (eg, warfarin): Chloramphenicol (Otina) (Systemic) may enhance the anticoagulant effect of Vitamin K Antagonists. Chloramphenicol (Otina) (Systemic) may increase the serum concentration of Vitamin K Antagonists. Monitor therapy

Voriconazole: Chloramphenicol (Otina) (Systemic) may increase the serum concentration of Voriconazole. Monitor therapy

See also:
What other drugs will affect Lidocaine (Otina)?

Beta-blockers increase the risk of bradycardia and hypotension. Norepinephrine and beta-blockers by reducing hepatic blood flow decrease (increased toxicity), isadrine and glucagon - increase the clearance of Lidocaine (Otina). Cimetidine increases the plasma concentration of Lidocaine (Otina) Haffkine Bio-Pharmaceutical Corporation (displaces from its association with proteins and slows inactivation in the liver). Barbiturates causing induction of microsomal enzymes stimulate the degradation of Lidocaine (Otina) and reduce its activity. Anticonvulsants (hydantoin derivatives) accelerate the biotransformation in the liver (decreased concentration in the blood), for IV injections it may increases cardiodepressive action of Lidocaine (Otina). Antiarrhythmics (amiodarone, verapamil, quinidine, aymalin) potentiate cardiac depression. Combination with novocainamide may cause CNS excitement and hallucinations. Lidocaine (Otina) Haffkine Bio-Pharmaceutical Corporation strengthens the inhibitory effect of anesthesia (hexobarbital, thiopental sodium), hypnotics and sedatives on the respiratory center, weakens the cardiac effects of digitoxin, enhances muscle relaxation caused by drugs curare like (possible paralysis of respiratory muscles). MAO inhibitors prolong local anesthesia.

See also:
What are the possible side effects of Betamethasone (Otina)?

Applies to Betamethasone (Otina) topical: topical application cream, topical application foam, topical application gel/jelly, topical application lotion, topical application ointment

Other dosage forms:

• topical application cream, topical application lotion, topical application ointment, topical application spray

In addition to its needed effects, some unwanted effects may be caused by Betamethasone (Otina) topical (the active ingredient contained in Betamethasone (Otina)). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Betamethasone (Otina) topical:

More common:

• Burning, itching, or stinging at the application site

• Hair loss
• thinning of the hair

• Blistering, burning, crusting, dryness, or flaking of the skin
• irritation
• itching, scaling, severe redness, soreness, or swelling of the skin
• redness and scaling around the mouth
• thinning of the skin with easy bruising, especially when used on where the skin folds together (e.g. between the fingers)

Minor Side Effects

Some of the side effects that can occur with Betamethasone (Otina) topical may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common:

• Acne or pimples
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

• Burning and itching of the skin with pinhead-sized red blisters
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color
• lightening of treated areas of dark skin
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin

See also:
What are the possible side effects of Chloramphenicol (Otina)?

1. Blood Dyscrasias

The most serious adverse effect of Chloramphenicol (Otina) is bone marrow depression. Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) are known to occur after the administration of Chloramphenicol (Otina). An irreversible type of marrow depression leading to aplastic anemia with a high rate of mortality is characterized by the appearance weeks or months after therapy of bone marrow aplastic or hypoplasia. Peripherally, pancytopenia is most often observed, but in a small number of cases only one or two of the three major cell types (erythrocytes, leukocytes, platelets) may be depressed.

A reversible type of bone marrow depression, which is dose related, may occur. This type of marrow depression is characterized by vacuolization of the erythroid cells, reduction of reticulocytes and leukopenia, and responds promptly to the withdrawal of Chloramphenicol (Otina).

An exact determination of the risk of serious and fatal blood dyscrasias is not possible because of lack of accurate information regarding 1) the size of the population at risk, 2) the total number of drug-associated dyscrasias, and 3) the total number of non-drug associated dyscrasias.

In a report to the California State Assembly by the California Medical Association and the State Department of Public Health in January 1967, the risk of fatal aplastic anemia was estimated at 1:24,200 to 1:40,500 based on two dosage levels.

There have been reports of aplastic anemia attributed to Chloramphenicol (Otina) which later terminated in leukemia.

Paroxysmal nocturnal hemoglobinuria has been reported.

2. Gastrointestinal Reactions

Nausea, vomiting, glossitis and stomatitis, diarrhea and enterocolitis may occur in low incidence.

3. Neurotoxic Reactions

Headache, mild depression, mental confusion, and delirium have been described in patients receiving Chloramphenicol (Otina). Optic and peripheral neuritis have been reported, usually following long-term therapy. If this occurs, the drug should be promptly withdrawn.

4. Hypersensitivity Reactions

Fever, macular and vesicular rashes, angioedema, urticaria, and anaphylaxis may occur. Herxheimer’s reactions have occurred during therapy for typhoid fever.

5. "Gray Syndrome"

Toxic reactions including fatalities have occurred in the premature and neonate; the signs and symptoms associated with these reactions have been referred to as the “gray syndrome.” One case of gray syndrome has been reported in a neonate born to a mother having received Chloramphenicol (Otina) during labor. One case has been reported in a 3-month-old infant. The following summarizes the clinical and laboratory studies that have been made on these patients:

a) In most cases therapy with Chloramphenicol (Otina) had been instituted within the first 48 hours of life.

b) Symptoms first appeared after 3 to 4 days of continued treatment with high doses of Chloramphenicol (Otina).

c) The symptoms appeared in the following order:

(1) abdominal distension with or without emesis;

(2) progressive pallid cyanosis;

(3) vasomotor collapse, frequently accompanied by irregular respiration;

(4) death within a few hours of onset of these symptoms.

d) The progression of symptoms from onset to exitus was accelerated with higher dose schedules.

e)Preliminary blood serum level studies revealed unusually high concentrations of Chloramphenicol (Otina) (over 90 mcg/mL after repeated doses).

f) Termination of therapy upon early evidence of the associated symptomatology frequently reversed the process with complete recovery.

See also:
What are the possible side effects of Lidocaine (Otina)?

Application Site Reactions

During or immediately after treatment with Lidocaine (Otina) 5%, the skin at the site of application may develop blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or may be the locus of abnormal sensation. These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours.

Allergic Reactions

Allergic and anaphylactoid reactions associated with Lidocaine (Otina), although rare, can occur. They are characterized by angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngospasm, pruritus, shock, and urticaria. If they occur, they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.

Other Adverse Events

Due to the nature and limitation of spontaneous reports in postmarketing surveillance, causality has not been established for additional reported adverse events including:

Asthenia, confusion, disorientation, dizziness, headache, hyperesthesia, hypoesthesia, lightheadedness, metallic taste, nausea, nervousness, pain exacerbated, paresthesia, somnolence, taste alteration, vomiting, visual disturbances such as blurred vision, flushing, tinnitus, and tremor.

Systemic (Dose-Related) Reactions

Systemic adverse reactions following appropriate use of Lidocaine (Otina) 5% are unlikely, due to the small dose absorbed. Systemic adverse effects of Lidocaine (Otina) are similar in nature to those observed with other amide local anesthetic agents, including CNS excitation and/or depression (light-headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest). Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness. Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest.

To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions.

Each gram of Betamethasone (Otina) (Betamethasone (Otina)*) Cream* contains: 640 mcg Betamethasone (Otina) dipropionate (equivalent to 500 mcg Betamethasone (Otina)).

Each gram of Betamethasone (Otina) (Betamethasone (Otina)*) Ointment* contains: 640 mcg Betamethasone (Otina) dipropionate (equivalent to 500 mcg Betamethasone (Otina)).

Betamethasone (Otina) (Betamethasone (Otina)*) Cream and Ointment contain Betamethasone (Otina) dipropionate, a synthetic corticosteroid with anti-inflammatory activity to be administered topically.

Betamethasone (Otina) dipropionate is a white to creamy white odorless crystalline powder insoluble in water; freely soluble in acetone and in chloroform; sparingly soluble in alcohol. It has a molecular weight of 504.16 and the empirical formula C₂₈H₃₇FO₇; a chemical name of 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione,17,21-dipropionate.

Each 100 g contains Chloramphenicol (Otina) 1 g.

Each gram contains Lidocaine (Otina) 50 mg equivalent to Lidocaine (Otina) 700 mg per 10 cm x 14 cm medicated plaster.

It also contains the following excipients: Self-Adhesive Layer: Glycerol, liquid sorbitol (crystallizing), carmellose sodium, propylene glycol (E1520), urea, heavy kaolin, tartaric acid, gelatin, polyvinyl alcohol, aluminum glycinate, disodium edetate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), polyacrylic acid, sodium polyacrylate, purified water.

Backing Fabric and Release Liner: Polyethylene terephthalate (PET).