RVP

Drug Catalog - Product Detail

Dvorah Tab 30CT

NDC Mfr Size Str Form
70362-0730-30 SKYLAR LABORATORIES 30 325-30-16MG TABLET
Product Image
Generic Name
Substance Name
Product Type
Route
Application Number
Description
DESCRIPTION DVORAH is supplied in tablet form for oral administration. Each tablet contains: Acetaminophen .................... 325 mg Caffeine ................................ 30 mg Dihydrocodeine bitartrate ........ 16 mg Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Caffeine (1,3,7-trimethylxanthine), a bitter, white crystalline powder or white glistening needles, is a central nervous system stimulant. It has the following structural formula: Dihydrocodeine Bitartrate (4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol (+)-tartrate), an odorless, fine white powder is an opioid analgesic. It has the following structural formula: Acetaminophen-Chemical structure Caffeine - Chemical Structure Dihydrocodeine Bitartrate - Chemical Structure In addition, each tablet also contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid.
How Supplied
HOW SUPPLIED DVORAH (acetaminophen, caffeine, and dihydrocodeine bitartrate tablets), containing acetaminophen 325 mg, caffeine 30 mg and dihydrocodeine bitartrate 16 mg, are supplied in bottles of 100 tablets (NDC 70362-730-01) and 30 tablets (NDC 70362-730-30). Tablets are white, capsule-shaped tablets debossed “LL 720” on one side and plain on the other side. Storage and Handling Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container with a child-resistant closure. Store DVORAH securely and dispose of properly [see PRECAUTIONS/ Information for Patients ]. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Rx Only Manufactured for: Skylar Laboratories, LLC. Canton, MS 39046 500474-04 Rev. 10/2019
Indications & Usage
INDICATIONS AND USAGE DVORAH is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS ], reserve DVORAH for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] Have not been tolerated, or are not expected to be tolerated Have not provided adequate analgesia, or are not expected to provide adequate analgesia
Dosage and Administration
DOSAGE AND ADMINISTRATION Important Dosage and Administration Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS ]. Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see WARNINGS ]. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with DVORAH and adjust the dosage accordingly [see WARNINGS ]. Initial Dosage Initiating treatment with DVORAH The usual adult dosage is two (2) DVORAH tablets orally every four (4) hours, as needed. No more than five (5) doses, or ten (10) tablets should be taken in a 24-hour period. Conversion from Other Opioids to DVORAH There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of DVORAH. It is safer to underestimate a patient’s 24-hour DVORAH dosage than to overestimate the 24-hour DVORAH dosage and manage an adverse reaction due to overdose. Titration and Maintenance of Therapy Individually titrate DVORAH to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving DVORAH to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see WARNINGS ]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the DVORAH dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions. Safe Reduction Discontinuation of DVORAH Do not abruptly discontinue DVORAH in patients who may be physically dependent on opioids. Rapid discontinuation of opioid analgesics in patients who are physically dependent on opioids has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. Patients may also attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances. When a decision has been made to decrease the dose or discontinue therapy in an opioid-dependent patient taking DVORAH, there are a variety of factors that should be considered, including the dose of DVORAH the patient has been taking, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. It is important to ensure ongoing care of the patient and to agree on an appropriate tapering schedule and follow-up plan so that patient and provider goals and expectations are clear and realistic. When opioid analgesics are being discontinued due to a suspected substance use disorder, evaluate and treat the patient, or refer for evaluation and treatment of the substance use disorder. Treatment should include evidence-based approaches, such as medication assisted treatment of opioid use disorder. Complex patients with co-morbid pain and substance use disorders may benefit from referral to a specialist. There are no standard opioid tapering schedules that are suitable for all patients. Good clinical practice dictates a patient-specific plan to taper the dose of the opioid gradually. For patients on DVORAH who are physically opioid-dependent, initiate the taper by a small enough increment (e.g., no greater than 10% to 25% of the total daily dose) to avoid withdrawal symptoms, and proceed with dose-lowering at an interval of every 2 to 4 weeks. Patients who have been taking opioids for briefer periods of time may tolerate a more rapid taper. It may be necessary to provide the patient with lower dosage strengths to accomplish a successful taper. Reassess the patient frequently to manage pain and withdrawal symptoms, should they emerge. Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. If withdrawal symptoms arise, it may be necessary to pause the taper for a period of time or raise the dose of the opioid analgesic to the previous dose, and then proceed with a slower taper. In addition, monitor patients for any changes in mood, emergence of suicidal thoughts, or use of other substances. When managing patients taking opioid analgesics, particularly those who have been treated for a long duration and/or with high doses for chronic pain, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper. A multimodal approach to pain management may optimize the treatment of chronic pain, as well as assist with the successful tapering of the opioid analgesic [see WARNINGS/ Withdrawal , DRUG ABUSE AND DEPENDENCE ].