DRUGS & SUPPLEMENTS
Cibis usesCibis consists of Camphor, Chlorpheniramine Maleate, Hexachlorophene, Lidocaine Hydrochloride, Menthol, Methyl Salicylate.
Cibis (Camphor) 0.70%
Uses : For the temporarily relief of pain and itching associated with:
- minor burn, sunburn - minor cuts, scrapes, insect bites
- minor skin problems.
|Active Ingredients (in each 1 mL dropperful)||Purpose|
|Cibis (Chlorpheniramine Maleate) Maleate 2 mg||Antihistamine|
|Phenylephrine HCl 5 mg||Nasal Decongestant|
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies
Do not exceed recommended dosage.
Ask a doctor before use if a child is taking sedatives or tranquilizers
Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
Do not exceed recommended dosage.
|Children 6 to under 12 years of age:||1 mL (1 dropperful) every 4 hours, not to exceed 6 mL in 24 hours or as directed by a doctor|
|Children 2 to under 6 years of age:||0.5 mL (1/2 dropperful) every 4 hours, not to exceed 3 mL in 24 hours, or as directed by a doctor|
|Children under 2 years of age:||Consult a doctor|
Store at 59°-86°F (15°-30°C)
Applesauce Flavor, Citric Acid, FD&C Blue #1, FD&C Yellow #6, Glycerin, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sucralose
Cibis (Chlorpheniramine Maleate)
Antihistamine ▪ Nasal Decongestant
Sugar Free ▪ Alcohol Free ▪ Gluten Free
FOR PROFESSIONAL USE ONLY
Each 1 mL for oral administration
Cibis (Chlorpheniramine Maleate) Maleate
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
Ripley, MS 38663
2 fl. oz. (60 mL)
Cibis (Hexachlorophene) is indicated for use as a surgical scrub and a bacteriostatic skin cleanser. It may also be used to control an outbreak of gram-positive infection where other infection control procedures have been unsuccessful. Use only as long as necessary for infection control.
Cibis (Hexachlorophene) must not be used on burned or denuded skin.
Cibis (Hexachlorophene) must not be used for bathing infants. Infants may absorb the active compound in Cibis (Hexachlorophene) more readily than older children and adults. Such absorption has been associated with central nervous system effects such as convulsions.
It must not be used as an occlusive dressing, wetpack, or lotion. It must not be used routinely for prophylactic total body bathing.
It must not be used as a vaginal pack or tampon, or on any mucous membranes.
Cibis (Hexachlorophene) must not be used on persons with sensitivity to any of its components. It must not be used on persons who have demonstrated primary light sensitivity to halogenated phenol derivatives because of the possibility of cross-sensitivity to Cibis (Hexachlorophene).
RINSE THOROUGHLY AFTER EACH USE. Patients should be closely monitored and use should be immediately discontinued at the first sign of any of the symptoms described below.
Rapid absorption of Cibis (Hexachlorophene) may occur with resultant toxic blood levels when preparations containing Cibis (Hexachlorophene) are applied to skin lesions such as ichthyosis congenita, the dermatitis of Letterer-Siwe's syndrome, or other generalized dermatological conditions. Application to burns has also produced neurotoxicity and death.
Cibis (Hexachlorophene) SHOULD BE DISCONTINUED PROMPTLY IF SIGNS OR SYMPTOMS OF CEREBRAL IRRITABILITY OCCUR.
Infants, especially premature infants or those with dermatoses, are particularly susceptible to Cibis (Hexachlorophene) absorption. Systemic toxicity may be manifested by signs of stimulation (irritation) of the central nervous system, sometimes with convulsions.
Infants have developed dermatitis, irritability, generalized clonic muscular contractions and decerebrate rigidity following application of a 6 percent Cibis (Hexachlorophene) powder. Examination of brainstems of those infants revealed vacuolization like that which can be produced in newborn experimental animals following repeated topical application of 3 percent Cibis (Hexachlorophene). Moreover, a study of histologic sections of premature infants who died of unrelated causes has shown a positive correlation between Cibis (Hexachlorophene) baths and lesions in white matter of brains.
Avoid accidental contact of Cibis with the eyes.
If contact occurs, promptly rinse thoroughly with water. To assist in the detection of ocular irritation, applications to the head and periorbital skin areas should be performed only in responsive patients with unanesthetized eyes.
RINSE THOROUGHLY AFTER USE, especially from sensitive areas such as the scrotum and perineum.
Cibis (Hexachlorophene) is intended for external use only. If swallowed, Cibis (Hexachlorophene) is harmful, especially to infants and children. Cibis (Hexachlorophene) should not be poured into measuring cups, medicine bottles, or similar containers since it may be mistaken for baby formula or other medications.
The prescribing physician is requested to inform the patient about the following precautionary measures:
Cibis (Hexachlorophene) must not be used on burned or denuded skin. Application to burns has produced neurotoxicity and death.
Cibis (Hexachlorophene) must not be used for bathing infants. Infants may absorb the active compound in Cibis (Hexachlorophene) more readily than older children and adults. Such absorption has been associated with central nervous system effects such as convulsions.
Cibis (Hexachlorophene) must not be used as an occlusive dressing, wetpack, or lotion.
Cibis (Hexachlorophene) must not be used routinely for prophylactic total body bathing.
Cibis (Hexachlorophene) must not be used as a vaginal pack, or on any mucous membranes.
Cibis (Hexachlorophene) must not be used on persons with sensitivity to any of its components.
Cibis (Hexachlorophene) must not be used on persons who have demonstrated primary light sensitivity to halogenated phenol derivatives because of the possibility of cross-sensitivity to Cibis (Hexachlorophene).
Cibis (Hexachlorophene) should be kept out of the eyes. If contact occurs, the patient should rinse with cold water as soon as possible and contact a physician.
Cibis (Hexachlorophene) should not be used in sensitive areas such as the scrotum and perineum. If contact occurs, these areas should be rinsed thoroughly.
Cibis (Hexachlorophene) is for external use only.
If Cibis (Hexachlorophene) is inadvertently swallowed, the patient should contact a physician or Poison Control Center as soon as possible.
Cibis (Hexachlorophene) should not be poured into measuring cups, medicine bottles, or similar containers since it may be mistaken for baby formula or other medications.
Cibis (Hexachlorophene) should be stopped and a physician should be contacted if irritation, sensitization, or allergic reaction occurs.
Cibis (Hexachlorophene) should be used in pregnant women or nursing mothers only if the potential benefit justifies the potential risk to the fetus or infant.
Cibis was tested in one experiment in rats by oral administration; it had no carcinogenic effect.
Cibis (Hexachlorophene) was not mutagenic in Salmonella typhimurium and was negative in a dominant lethal assay in male mice. Cytogenetic tests with cultured human lymphocytes were also negative.
No case reports or epidemiological studies were available.
Topical exposure of neonatal rats to 3% Cibis solution caused reduced fertility in 7-month-old males, due to inability to ejaculate.
Placental transfer of Cibis (Hexachlorophene) has been demonstrated in rats.
Cibis (Hexachlorophene) is embryotoxic and produces some teratogenic effects.
Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women. Cibis (Hexachlorophene) should be used during pregnancy only if the potential benefit justifies potential risk to the fetus.
Cibis (Hexachlorophene) has been shown to be teratogenic and embryotoxic in rats when given by mouth or instilled into the vagina in large doses.
Administration of 500 mg/kg diet or 20 to 30 mg/kg bw/day by gavage to rats caused some malformations (angulated ribs, cleft palate, micro- and anophthalmia) and reduction in litter size.
Placental transfer and excretion in milk of Cibis (Hexachlorophene) has been demonstrated in rats.
In another study, doses of up to 50 mg/kg diet failed to produce any effects in 3 generations of rats. Cibis (Hexachlorophene) did not interfere with reproduction in hamsters.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Cibis, a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.
Cibis (Hexachlorophene) must not be used for bathing infants. Infants may absorb the active compound in Cibis (Hexachlorophene) more readily than older children and adults. Such absorption has been associated with central nervous system effects such as convulsions. For premature infants: see WARNINGS.
Clinical studies of Cibis (Hexachlorophene) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients. In general, use in elderly patients should be cautious, reflecting the greater frequency of dermatological disease, peripheral circulatory disease, and decreased propensity for wound healing in this group. In addition, use in elderly patients should take into account any decreased hepatic, renal, or cardiac function, as well as any concomitant disease or other drug therapy.
Adverse reactions to Cibis (Hexachlorophene) may include dermatitis and photosensitivity. Sensitivity to Cibis (Hexachlorophene) is rare; however, persons who have developed photoallergy to similar compounds also may become sensitive to Cibis (Hexachlorophene).
In persons with highly sensitive skin the use of Cibis (Hexachlorophene) may at times produce a reaction characterized by redness and/or mild scaling or dryness, especially when it is combined with such mechanical factors as excessive rubbing or exposure to heat or cold.
The accidental ingestion of Cibis (Hexachlorophene) in amounts from 1 oz to 4 oz has caused anorexia, vomiting, abdominal cramps, diarrhea, dehydration, convulsions, hypotension, and shock, and in several reported instances, fatalities.
If patients are seen early, the stomach should be evacuated by emesis or gastric lavage. Olive oil or vegetable oil (60 mL or 2 fl oz) may then be given to delay absorption of Cibis (Hexachlorophene), followed by a saline cathartic to hasten removal. Treatment is symptomatic and supportive; intravenous fluids (5 percent dextrose in physiologic saline solution) may be given for dehydration. Any other electrolyte derangement should be corrected. If marked hypotension occurs, vasopressor therapy is indicated. Use of opiates may be considered if gastrointestinal symptoms (cramping, diarrhea) are severe. Scheduled medical or surgical procedures should be postponed until the patient's condition has been evaluated and stabilized.
Wet hands with water. Dispense approximately 5 mL of Cibis (Hexachlorophene) into the palm, work up a lather with water and apply to area to be cleansed.
Rinse thoroughly after each washing.
Cibis must not be used for bathing infants. Infants may absorb the active compound in Cibis (Hexachlorophene) more readily than older children and adults. Such absorption has been associated with central nervous system effects such as convulsions.
Use of baby skin products containing alcohol may decrease the antibacterial action of Cibis (Hexachlorophene).
5 oz plastic squeeze bottle.
1 pint plastic squeeze bottle (NDC 0024-1535-06).
Store at room temperature up to 25° C (77° F)
Prolonged direct exposure of Cibis (Hexachlorophene) to strong light may cause brownish surface discoloration but does not affect its antibacterial or detergent properties. Shaking will disperse the color. If Cibis (Hexachlorophene) is spilled or splashed on porous surfaces, rinse off to avoid discoloration.
Cibis (Hexachlorophene) should not be dispensed from, or stored in, containers with ordinary metal parts. A special type of stainless steel must be used or undesirable discoloration of the product or oxidation of metal may occur.
Before initial installation and use, run an antiseptic, such as an aqueous solution of benzalkonium chloride, NF. 1:500 to 1:750, or alcohol, through the working parts; rinse with sterile water. At weekly intervals thereafter, remove dispenser and pour off remainder of Cibis (Hexachlorophene) emulsion. Rinse empty dispenser with water. Run water through the working parts by operating the dispenser. Sanitize as described above. Rinse thoroughly with sterile water.
The oral LD50 of Cibis (Hexachlorophene) in male rats is 66 mg/kg bw, in females 56 mg/kg bw, and in weanling rats 120 mg/kg bw.
In suckling rats (10-days old), it is 9 mg/kg bw.
sanofi-aventis U.S. LLC, A SANOFI COMPANY
Bridgewater, NJ 08807
Revised January 2012
© 2012 sanofi-aventis U.S. LLC
148 mL (5 fl oz)
Cibis (Hexachlorophene) 3%
For inquiries call 1-800-446-6267
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY
Cibis is an antiarrhythmic agent of class IB, local anesthetic, a derivative of acetanilide. This medication has membrane stabilizing activity. Cibis (Lidocaine Hydrochloride) causes a blockade of sodium channels of excitable membranes of neurons and the membrane of cardiomyocytes.
This drug reduces the duration of the action potential and effective refractory period in Purkinje fibers, inhibits their automaticity. In this case, Cibis (Lidocaine Hydrochloride) inhibits electrical activity in depolarized, arrhythmogenic sites, but minimally affects the electrical activity of normal tissues. When used in the medium therapeutic doses virtually no effect on myocardial contractility and slows AV-conduction. When applied as an antiarrhythmic agent in IV injection it begin to act in 45-90 seconds, the duration of action is 10-20 minutes; for IM administration the onset of action is in 5-15 minutes, the duration - 60-90 minutes.
Cibis (Lidocaine Hydrochloride) causes all kinds of local anesthesia: a terminal, infiltration and wires.
After IM administration absorption of Cibis (Lidocaine Hydrochloride) is almost complete. The distribution is rapid, Vd is about 1 L/kg (in patients with heart failure it is below). The protein binding depends on the concentration of the active substance in the plasma and is 60-80%. Cibis (Lidocaine Hydrochloride) metabolized mainly in the liver with the formation of active metabolites, that may contribute to the manifestation of the therapeutic and toxic effects, especially after the infusion for 24 hours or more.
T1/2 tends to be two phases with the phase distribution of 9.7 min. In general T1/2 depends on the dose is 1-2 hours and can grow up to 3 hours or more during prolonged intravenous infusion (over 24 h). Cibis (Lidocaine Hydrochloride) excreted by the kidneys as metabolites, 10% unchanged.
In cardiological practice: treatment and prevention of ventricular arrhythmias (extrasystoles, tachycardia, atrial flutter, atrial fibrillation), including in acute myocardial infarction, implantation of artificial pacemaker in the glycoside intoxication, narcosis.
Anaesthesia: terminal, infiltration, conduction, spinal (epidural) anesthesia in surgery, obstetrics and gynecology, urology, ophthalmology, dentistry, otolaryngology, blockade of peripheral nerves and ganglion.
As an anti-arrhythmic medicine for adult with the introduction of a loading dose by IV - 1-2 mg / kg over 3-4 minutes; the average single dose is 80 mg. Then immediately transferred to drip infusion at a rate of 20-55 mg / kg / min. Drip infusion can be carried out within 24-36 hours. If necessary, against the background of drop infusions can repeat IV jet injection of Cibis 40 mg after 10 minutes after the first loading dose.
IM is introduced to 2-4 mg / kg, if necessary, repeated administration is possible through 60-90 minutes.
For children with IV injection loading dose - 1 mg / kg, if necessary, it may be repeated administration in 5 min.
For continuous intravenous infusion (usually following the introduction of a loading dose) - 20-30 mg / kg / min.
For use in surgical and obstetric practice, dentistry, ENT practice, dosing regimen set individually, depending on the evidence, the clinical situation and used the dosage form.
Maximum dose: for adults for IV injections the loading dose is 100 mg, in a subsequent drop infusion it is 2 mg / min; when IM administration - 300 mg (about 4.5 mg / kg) for 1 h.
For children in case of reintroduction the loading dose every 5 minutes, the total dose is 3 mg / kg; by continuous intravenous infusion (usually following the introduction of a loading dose) - 50 mg / kg / min.
CNS and peripheral nervous system: dizziness, headache, weakness, motor restlessness, nystagmus, loss of consciousness, drowsiness, visual and auditory disturbances, tremor, trismus, seizures (risk of their development against the backdrop of increasing hypercapnia and acidosis), a syndrome of "cauda equina" (paralysis of the legs, paresthesia), paralysis of respiratory muscles, respiratory arrest, a block of motor and sensitive, respiratory paralysis (usually develops in the subarachnoid anesthesia), numb tongue (when used in dentistry).
Cardiovascular system: increased or decreased blood pressure, tachycardia if used with a vasoconstrictor, peripheral vasodilatation, collapse, chest pain.
Digestive system: nausea, vomiting, involuntary defecation.
Allergic reactions: skin rash, hives (on skin and mucous membranes), itching, angioedema, anaphylactic shock.
Local reactions: during spinal anesthesia - a pain in the back, with an epidural anesthesia - a random hit in the subarachnoid space, when applied topically in urology - urethritis.
Other: incontinent, methemoglobinemia, persistent anesthesia, decreased libido and / or potency, respiratory depression, until the stop, hypothermia; during anesthesia in dentistry: numbness and paresthesia of the lips and tongue, the lengthening of anesthesia.
Severe bleeding, shock, hypotension, infection of the proposed injection site, marked bradycardia, cardiogenic shock, severe forms of chronic heart failure, SSS in elderly patients, AV-block II and III degree (except in cases when the probe was introduced to stimulate the ventricles), severe liver function abnormalities.
For subarachnoid anesthesia - complete heart block, bleeding, hypotension, shock, infection of the venue lumbar puncture, septicemia.
Increased sensitivity to Cibis (Lidocaine Hydrochloride) and other amide type local anesthetics.
During pregnancy and lactation be used only for health reasons. Cibis is excreted in breast milk.
In obstetric practice used with caution in paracervical for violations of fetal development, placental insufficiency, prematurity, postmaturity, gestosis.
Category effects on the fetus by FDA - B.
Use with caution in liver disease and kidney failure, hypovolemia, severe heart failure, in violation of the contractility of genetic susceptibility to malignant hyperthermia. In children, debilitated patients, elderly patients are required in dosage adjustment in accordance with the age and physical status. When injected into vascularized tissue it is recommended an aspiration test.
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 Cibis (Lidocaine Hydrochloride). Cimetidine increases the plasma concentration of Cibis (Lidocaine Hydrochloride) (displaces from its association with proteins and slows inactivation in the liver). Barbiturates causing induction of microsomal enzymes stimulate the degradation of Cibis (Lidocaine Hydrochloride) 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 Cibis (Lidocaine Hydrochloride). Antiarrhythmics (amiodarone, verapamil, quinidine, aymalin) potentiate cardiac depression. Combination with novocainamide may cause CNS excitement and hallucinations. Cibis (Lidocaine Hydrochloride) 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.
Symptoms: psychomotor agitation, dizziness, weakness, decreased blood pressure, tremors, tonic-clonic convulsions, coma, collapse, possible AV blockade, CNS depression, respiratory arrest.
Treatment: discontinuation, pulmonary ventilation, oxygen therapy, anticonvulsants, vasoconstrictors (norepinephrine, mezaton), when bradycardia - anticholinergics (atropine). It is possible to carry out intubation, mechanical ventilation, resuscitation. Dialysis is ineffective.
Indication: Used to treat occasional minor irritation, pain, sore mouth, and sore throat as well as cough associated with a cold or inhaled irritants.
Cibis (Menthol) is a covalent organic compound made synthetically or obtained from peppermint or other mint oils. Menthol's ability to chemically trigger cold-sensitive receptors in the skin is responsible for the well known cooling sensation that it provokes when inhalated, eaten, or applied to the skin. It should be noted that Cibis (Menthol) does not cause an actual drop in temperature.
Cibis (Methyl Salicylate) Cream in combination with 570 to 670 nm wavelength red light illumination using the CureLight BroadBand Model CureLight 01 lamp is indicated for treatment of non-hyperkeratotic actinic keratoses of the face and scalp in immunocompetent patients when used in conjunction with lesion preparation (debridement using a sharp dermal curette) in the physician’s office when other therapies are unacceptable or considered medically less appropriate.
Cibis (Methyl Salicylate) Cream is contraindicated in patients with cutaneous photosensitivity, or known allergies to porphyrins, and in patients with known sensitivities to any of the components of Cibis (Methyl Salicylate) Cream, which includes peanut and almond oil Cream).
Cibis (Methyl Salicylate) Cream is intended for topical use in the physician’s office by trained physicians only. Do not apply to the eyes or to mucous membranes.
Cibis (Methyl Salicylate) Cream has demonstrated a high rate of contact sensitization (allergenicity). Care should be taken by the physician applying Cibis (Methyl Salicylate) Cream to avoid inadvertent skin contact. Nitrile gloves should be worn when applying and removing the cream. Vinyl and latex gloves do not provide adequate protection when using this product.Cibis (Methyl Salicylate) Cream when used with CureLight BroadBand Model CureLight 01 lamp must be used with appropriate protective sleeves obtained from the product manufacturer to decrease the risk of blood-borne transmitted diseases (hepatitis, HIV, etc.). Change the disposable covers for the device (probe and horseshoe positioning device) between patients. Universal Precautions should be used with this treatment.
The safety and efficacy have not been established for the treatment of cutaneous malignancies and for skin lesions other than non-hyperkeratotic face and scalp actinic keratoses using PDT with Cibis Cream. Thick (hyperkeratotic) actinic keratoses should not be treated with Cibis (Methyl Salicylate) Cream. The safety and efficacy of Cibis (Methyl Salicylate) Cream has not been established in patients with immunosuppression, porphyria or pigmented actinic keratoses.
Cibis (Methyl Salicylate) Cream Application
During the time period between the application of Cibis (Methyl Salicylate) (methyl aminolevulinate) Cream and exposure to red light illumination, the treatment site will become photosensitive. After Cibis (Methyl Salicylate) Cream application, patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) during the period prior to red light treatment. Exposure to light may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions. Before exposure to sunlight, patients should, therefore, protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material. Sunscreens will not protect against photosensitivity reactions caused by visible light. The treated site should be protected from extreme cold with adequate clothing or remaining indoors between application of Cibis (Methyl Salicylate) and PDT light treatment. After illumination of Cibis (Methyl Salicylate) Cream, the area treated should be kept covered and away from light for at least 48 hours. Because of the potential for skin to become photosensitized, the Cibis (Methyl Salicylate) Cream should be used by a trained physician to apply drug only to non-hyperkeratotic actinic keratoses and perilesional skin within 5 mm of the lesion. Redness, swelling, burning, and stinging are expected as a result of therapy; however, if these symptoms increase in severity and persist longer than 3 weeks, the patient should contact their doctor. Metvixia Cream has not been studied for more than two treatment sessions. Information regarding further treatments for residual or new AK lesions performed after 3 months is not available..
The patient, operator and other persons present should wear protective goggles that sufficiently screen out light with wavelengths from 570 to 670 nm during red light treatment.
If for any reason the patient cannot have the red light treatment after application of Cibis Cream, the cream should be rinsed off, and the patient should protect the treated area from sunlight, prolonged or intense light for two days. Prolonged exposure for greater than 4 hours to Cibis (Methyl Salicylate) Cream should be avoided.
Cibis (Methyl Salicylate) Cream has not been tested on patients with inherited or acquired coagulation defects.
Cibis Cream is formulated with refined peanut and almond oil.
Cibis (Methyl Salicylate) (methyl aminolevulinate) Cream has not been tested in patients who are allergic to peanuts. Cibis (Methyl Salicylate) (methyl aminolevulinate) Cream has demonstrated a high rate of contact sensitization (allergenicity).
The physician should provide and discuss the attached Patient Package Insert with each patient.
There have been no studies of the interaction of Cibis Cream with any other drugs, including local anesthetics. It is possible that concomitant use of other known photosensitizing agents might increase the photosensitivity reaction of actinic keratoses treated with Cibis (Methyl Salicylate) Cream.
Long-term studies to evaluate the carcinogenic potential of Cibis (Methyl Salicylate) Cream have not been performed.
Cibis (Methyl Salicylate) aminolevulinate was negative for genetic toxicity in the Ames assay, and the chromosomal aberration assay in Chinese hamster ovary cells, tested with and without metabolic activation and in the presence and absence of light. Cibis (Methyl Salicylate) aminolevulinate was also negative in the in vivo micronucleus assay in the rat. In contrast, at least one report in the literature has noted genotoxic effects in cultured rat hepatocytes after aminolevulinate (ALA) exposure with PpIX formation. Other studies have documented oxidative DNA damage in vivo and in vitro as a result of ALA exposure. No animal fertility studies have been conducted.
Pregnancy Category C: Animal reproduction studies have not been conducted with Cibis Cream. It is also not known whether Cibis (Methyl Salicylate) Cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Cibis (Methyl Salicylate) Cream should be given to a pregnant woman only if clearly needed.
The amount of Cibis (Methyl Salicylate) aminolevulinate secreted into human breast milk following topical administration of Cibis (Methyl Salicylate) Cream is not known. Because many drugs are secreted in human milk, caution should be exercised when Cibis (Methyl Salicylate) Cream is administered to a nursing mother. If Cibis (Methyl Salicylate) Cream is used in a nursing mother, a decision should be made whether or not to stop nursing.
It is not recommended that Cibis Cream be used in pediatric patients. Actinic keratosis is rarely found in pediatric patients.
Seventy percent (269 among 383) of the patients treated with Cibis (Methyl Salicylate) Cream in all clinical studies of actinic keratosis were 65 years of age or older. No overall differences in safety and efficacy were observed between patients aged 65 years and older and those who were younger.
Provocative studies to evaluate irritancy and sensitization have demonstrated that Cibis Cream is an irritant and sensitizer. A provocative cumulative irritancy and sensitization (allergenicity) study of Cibis (Methyl Salicylate) Cream with a cross-sensitization challenge with ALA was performed in 156 subjects. Only 98 of the 156 subjects tested entered the challenge phase. Fifty-two percent of the subjects (30/58), who agreed to challenge with Cibis (Methyl Salicylate) Cream, were positive (sensitized). Forty subjects refused challenge with Cibis (Methyl Salicylate) Cream and 60 withdrew. At least 58 of the 60 subjects who withdrew from the study discontinued due to irritation/sensitization.
Ninety-eight subjects agreed to challenge with ALA. Two percent of the ALA challenged subjects (2/98) were scored as equivocal reactions and 2% in the paraffin vehicle group were scored as positive.
In vehicle-controlled phase 3 studies of actinic keratosis, 88% of patients treated with Cibis (Methyl Salicylate) Cream reported one or more adverse events.
Burning was the most frequent complaint, reported by 50% of patients (ranging from mild, to severe) and 9% of those patients reported severe burning sensation. Pain in the skin was reported by 21% of patients and 7% had severe pain. Local erythema lasting up to two weeks and edema up to one week after treatment were reported by 31% and 6% of patients. Symptoms and signs of local phototoxicity were observed in 88% of patients treated with Cibis (Methyl Salicylate) Cream in all clinical studies of Cibis (Methyl Salicylate) -PDT for actinic keratoses.
|n (%) of patients with AEs||n (%) of patients with AEs|
|Burning sensation skin||65 (50.0%)||9 (14.8%)|
|Erythema||60 (46.2%)||12 (19.7%)|
|Skin pain||27 (20.8%)||6 (9.8%)|
|Stinging skin||25 (19.2%)||2 (3.3%)|
|Crusting||20 (15.4%)||6 (9.8%)|
|Edema skin||20 (15.4%)||1 (1.6%)|
|Skin peeling||14 (10.8%)||2 (3.3%)|
|Blisters||14 (10.8%)||2 (3.3%)|
|Bleeding skin||11 (8.5%)||2 (3.3%)|
|Pruritus/Itching||17 (13.1%)||2 (3.3%)|
|Skin ulceration||7 (5.4%)||0 (0%)|
|Skin infection||3 (2.3%)||1 (1.6%)|
|Skin hyper-pigmentation||1 (0.8%)||0 (0%)|
The majority of patients in all the clinical trials had local pain or discomfort upon illumination. There were 4 (1.0%) withdrawals/discontinuations among 383 patients treated with Cibis (Methyl Salicylate) Cream in all the clinical trials of actinic keratosis, all of which were due to the adverse event of local pain on illumination.
There have been reported instances of patients treated with Cibis (Methyl Salicylate) Cream (2 out of 130) who have developed squamous cell and basal cell carcinoma at the site of treatment. The relationship to treatment with Cibis (Methyl Salicylate) Cream is unknown. Serious erythema and facial edema have been described in European post-marketing reports.
Cibis (Methyl Salicylate) Cream overdose has not been reported. If the patient for any reason cannot have the red light treatment during the prescribed period after application (the 3 hour timespan), the cream should be rinsed off, and the patient should protect the exposed area from sunlight, prolonged or intense light for two days.
There is no information on overdose of red light following Cibis (Methyl Salicylate) Cream application.
Photodynamic therapy for non-hyperkeratotic actinic keratoses with Cibis (Methyl Salicylate) Cream is a multi-stage process as described below: Two treatment sessions 7 days apart should be conducted. Not more than one gram (half a tube) of Cibis (Methyl Salicylate) Cream should be applied per treatment session.
One Cibis (Methyl Salicylate) -PDT session consists of: 1) Lesion debriding –
Before applying Cibis (Methyl Salicylate) Cream, the surface of the lesions should be prepared with a small dermal curette to remove scales and crusts and roughen the surface of the lesion. This is to facilitate access of the cream and light to all parts of the lesion.
Figure 1 A Lesion debriding Only nitrile gloves should be worn during this and subsequent steps and Universal Precautions should be taken. Vinyl and latex gloves do not provide adequate protection when using this product.
Figure 1B Lesion debriding2) Application of Cibis (Methyl Salicylate) Cream –
Using a spatula, apply a layer of Cibis (Methyl Salicylate) Cream about 1 mm thick to the lesion and the surrounding 5 mm of normal skin. Do not apply more than one gram of Cibis (Methyl Salicylate) Cream for each patient per treatment session.
Figure 2: Cream applicationThe area to which the cream has been applied should then be covered with an occlusive, non-absorbent dressing for 3 hours. Multiple lesions may be treated during the same treatment session. Each treatment field is limited to a diameter of 55 mm. Only nitrile gloves should be worn by the qualified healthcare provider in order to avoid skin contact with the cream. This product is not intended for application by patients or unqualified medical personnel.
Figure 3: Occlusive dressing application3) Wait for 3 hours - (at least 2.5 hours, but no more than 4 hours).
After Cream application, patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) during the period prior to red light treatment. Exposure to light may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions. Patients should protect treated areas from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material. Sunscreens will not protect against photosensitivity reactions caused by visible light. It has not been determined if perspiration can spread the Cibis (Methyl Salicylate) Cream outside the treatment site to the eyes or surrounding skin. The treated site should be protected from extreme cold with adequate clothing or remaining indoors between application of Cibis (Methyl Salicylate) Cream and PDT light treatment.4) Removal of Dressing and Rinse Off Excess Cream - Following removal of the occlusive dressing, clean the area with saline and gauze. Nitrile gloves should be worn at this step by the trained physician.
Figure 4: Cream removal5) Illumination of Cibis (Methyl Salicylate) Treated Lesion - It is important to ensure that the correct light dose is administered. The light intensity at the lesion surface should not be higher than 200 mW/cm2. Patient and operator should adhere to safety instructions and Universal Precautions provided with the lamp. The patient and operator should wear protective goggles during illumination. Patients should be advised that transient stinging and/or burning at the target lesion sites may occur during the period of light exposure.
Figure 5: IlluminationThe CureLight BroadBand Model CureLight 01 lamp is approved for the use in Cibis (Methyl Salicylate) -PDT. The lamp should be carefully calibrated so that dosing is accurate and immediately thereafter the lesion should be exposed to red light with a continuous spectrum of 570 to 670 nm and a total light dose of 75 J/cm2. To avoid direct contact between lamp parts and patient skin, always use disposable protective plastic sleeves on the positioning device and on the light measuring probe. Following each patient treatment, the disposable protective plastic sleeves should be removed from the positioning device and from the light measuring probe and discarded. If red light treatment is interrupted or stopped for any reason, it may be restarted. If the patient for any reason cannot have the red light treatment during the prescribed period after application (the 3 hour timespan), the cream should be rinsed off and the patient should protect the exposed area from sunlight, prolonged or intense light for two days. Cibis (Methyl Salicylate) Cream is not intended for use with any device other than the approved lamp: CureLight BroadBand Model CureLight 01. Use of Cibis (Methyl Salicylate) Cream without subsequent red light illumination is not recommended. No more than 1 gram (half a tube) of product should be used for each of the two weekly treatment sessions. Multiple lesions may be treated during the same treatment session using a total of 1 gram of Cibis (Methyl Salicylate) Cream. Lesion response should be assessed 3 months after the last treatment session. This product is not intended for application by patients or unqualified medical personnel, therefore, this product is only dispensed to physicians.
Cibis Cream, 16.8%, is available as the following:
NDC 63069-401-01, 2 gram aluminum tube, box of 1
Keep out of reach of children
For topical use only by physicians in the physician’s office. Rx Only
Store refrigerated, 2-8°C.
Use contents within one week after opening.
Should not be used after 24 hours out of refrigerator.
Metvixia Cream is a registered trade name of PhotoCure ASA.
PhotoCure ASA, Hoffsveien 48, N-0377 Oslo, Norway
USA Contact: Cato Research, Westpark Corporate Center, 4364 South Alston Avenue, Durham NC 27713
Revision: September 5, 2007
Cibis (Methyl Salicylate)™ Cream 16.8% (phonetic)
Generic name: Cibis (Methyl Salicylate) aminolevulinate hydrochloride
Read this Patient Information before you get treated with Cibis (Methyl Salicylate) Cream and each time you get a treatment. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment. Ask your healthcare provider about anything you do not understand about Cibis (Methyl Salicylate) Cream.
Cibis (Methyl Salicylate) Cream is a prescription cream used with PDT (light treatment) to treat skin growths on the face and scalp called actinic keratosis (AK). Cibis (Methyl Salicylate) Cream is only used for AK skin growths that are thin and not dark colored. AK skin growths are not cancer. AK skin growths are caused partly by too much sun exposure. Cibis (Methyl Salicylate) Cream and PDT work together to treat AK skin growths.
Cibis (Methyl Salicylate) Cream has not been studied in children for any condition and should not be used in children.
Do not use Cibis (Methyl Salicylate) Cream if:
During the 3 hours that Cibis (Methyl Salicylate) Cream is on your skin:
Common side effects of Cibis (Methyl Salicylate) Cream with PDT treatment include the following skin reactions at the treated site:
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.
This leaflet summarizes the most important information about Cibis (Methyl Salicylate) Cream. If you would like more information, talk with your doctor. You can ask your doctor for information about Cibis (Methyl Salicylate) Cream that is written for health professionals. Toll-free number and/or website will be provided when available for the US market.
Active Ingredient: Cibis (Methyl Salicylate) aminolevulinate hydrochloride
Other Ingredients: Glyceryl monostearate, cetostearyl alcohol, poloxyl stearate, cholesterol, oleyl alcohol glycerin, white petrolatum, isopropyl myristate, refined peanut oil, refined almond oil, edetate disodium, methylparaben and propylparaben. The color of the product is cream to pale yellow.
Figure 1: Lesion debriding
Your doctor will prepare your skin by gently scraping (debriding) your skin growths before treating with Cibis (Methyl Salicylate) Cream and PDT. A small skin scraper is used to remove scales and crusts and to roughen the surface of any skin growths. This is to help Cibis (Methyl Salicylate) Cream and PDT to reach all parts of the skin growths.
Figure 2: Cream application Metvixia Cream is applied to the actinic keratosis skin growths and to a small area of the skin around the growths.
Figure 3: Clear bandage application The treated skin areas will be covered with a special clear bandage for about 3 hours.
During these 3-hours you should avoid exposure of treated area to sunlight or bright indoor light. Exposure to light may make your treated skin area sting or burn. Your treated skin area may turn red or swell (photosensitive reactions). Wear a hat and protective clothes if you are exposed to sunlight during this time. Sunscreens will not help protect your treated skin during this time. In cold weather, your treated skin site should be protected from the cold with warm clothes or you should stay indoors for these 3 hours between the cream and light treatment.
Figure 4: Cream removal The clear bandage will be removed and the area will be rinsed with a saline solution before the PDT (light) treatment.
Figure 5: IlluminationThe skin growth will be treated with PDT. PDT lasts about 10 minutes for each area treated with the lamp. You will wear protective goggles to cover your eyes during this part of the treatment. More than 1 skin growth may be treated at a time. Your treated skin areas may burn, feel painful, sting, or tingle during light treatment. These symptoms may last for a few hours after the treatment. If you cannot have the light treatment 3 hours after Cibis (Methyl Salicylate) Cream is applied, rinse the cream off your skin and you must protect your skin from sunlight and bright indoor light for 2 days. This product should only be stored in refrigerators in pharmacies and medical offices. Rx only
Cibis (Methyl Salicylate) Cream is a registered trade name of PhotoCure ASA.
Sponsor: PhotoCure ASA, Hoffsveien 48, NO-0377 Oslo, Norway
U.S. Contact: Cato Research, Westpark Corporate Center, 4364 South Alston Avenue, Durham NC 27713
Manufacturer: Penn Pharmaceutical Services Ltd., Tafarnaubach Industrial Estate, Tredegar, Gwent, NP22 3AA, UK.
Depending on the reaction of the Cibis after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Cibis not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Cibis addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Arunabha Ray, MD Pharmacology