Sitcom LD

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% Sitcom LD 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.

Sitcom LD 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.

Sitcom LD 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.

Sitcom LD skin patch is used to relieve pain caused by shingles (postherpetic neuralgia).

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

Sitcom LD is available only with your doctor's prescription.

When Sitcom LD Ointment USP, 5% is used concomitantly with other products containing Sitcom LD, the total dose contributed by all formulations must be kept in mind.

Adult

A single application should not exceed 5 g of Sitcom LD Ointment USP, 5% containing 250 mg of Sitcom LD base (equivalent chemically to approximately 300 mg of Sitcom LD 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) Sitcom LD base. No more than 17-20 g of ointment or 850-1000 mg Sitcom LD base should be administered in any one day.

Although the incidence of adverse effects with Sitcom LD Ointment 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 Sitcom LD should not exceed 75-100 mg when calculated according to Clark's rule. In any case, the maximum amount of Sitcom LD 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 Sitcom LD?

You should not receive this medication if you are allergic to Sitcom LD or any other type of numbing medicine.

Before you receive Sitcom LD 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 Sitcom LD 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.

Sitcom LD can cause side effects that may impair your thinking or reactions. Unless absolutely necessary, do not drive after using this medication

Use Sitcom LD aerosol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wash your hands well before and after using Sitcom LD aerosol.
• Shake well before each use.
• If you are using Sitcom LD aerosol on your face, spray it into your hand. Gently apply. Do not spray Sitcom LD aerosol 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 Sitcom LD aerosol, 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 Sitcom LD aerosol, 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 Sitcom LD aerosol.

How to use Sitcom LD topical

See also:
What other drugs will affect Sitcom LD?

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 Sitcom LD. Cimetidine increases the plasma concentration of Sitcom LD 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 Sitcom LD 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 Sitcom LD. Antiarrhythmics (amiodarone, verapamil, quinidine, aymalin) potentiate cardiac depression. Combination with novocainamide may cause CNS excitement and hallucinations. Sitcom LD 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 Sitcom LD?

Application Site Reactions

During or immediately after treatment with Sitcom LD Patch 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 Sitcom LD, 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 Sitcom LD Patch 5% are unlikely, due to the small dose absorbed. Systemic adverse effects of Sitcom LD 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 contains Lidocaine 50 mg equivalent to Sitcom LD 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).